FP-00022

Section 1 - Basic information about you and your application:

Title of research project
Couch to Healthy Bones (C2HB) Programme

Grant Type
The ORUK Inspiration Fund

Research area
Treatment

Duration
12

Start date
March 4, 2024

Have you previously received funding from ORUK?
No.

Profession
Academic scientist

Your current job title/position
Lecturer

Are you an early-career researcher (ECR)? (definition of ECR)
yes

Section 2 - Lay summary

Lay summary:

1- We aim to reduce the risks of osteoporosis and promote bone health in peri and post-menopausal women using digital technology (a newly developed Couch to Healthy Bones iOS-based app [C2HB]).

2- In the UK, approximately one in two women and one in five men aged over 50 will experience an osteoporotic fracture during their lifetime (1). Globally, around 200 million women are affected by osteoporosis (2).  Projections indicate a significant rise in the incidence of hip fractures, a common type of osteoporotic fracture, with an estimated increase of 240% in men and 310% in women by the year 2050 (2).

3- Our ambition is to employ resistance and impact training as a preventive measure for reducing osteoporosis-related fractures, utilising innovative digital technology as the medium for implementation. By incorporating our existing C2HB app into everyday lifestyles, and creating a new ‘Healthy Bones’ website we aim to make this treatment option affordable and inclusive, allowing it to reach a wider population both nationally and internationally. The C2HB app is the first of its kind to provide practical and meaningful support by offering bespoke bone-strengthening exercises, real-time progress tracking, and delivering valuable nutritional knowledge to aid in the prevention of osteoporosis.

The interaction between skeletal muscle and bone, known as the ‘muscle-bone unit’, plays a crucial role in coordinating the development and response to loading or injury of these two tissues. It has been observed that both Sarcopenia (age-related muscle loss) and Osteoporosis (reduced bone density) often occur together in individuals. Targeted resistance and impact exercises have the ability to address both Sarcopenia and Osteoporosis simultaneously, which can reduce the risk of fracture and promote better movement in individuals with musculoskeletal (MSK) conditions.

We plan to disseminate our research findings to eligible local populations with MSK conditions using lay terms. We will take advantage of our established relationships with the Osteoporosis Research in East Yorkshire (OSPREY), Neighbourhood Network, and the XXX University menopause network to organise these seminars. Additionally, we intend to raise awareness on a national scale by establishing a research-informed ‘Healthy Bones’ website. This platform will serve as an informational hub, offering educational content related to bone health.

4- We have devised multiple strategies to involve people with MSK conditions in our research. We will establish a public advisory group that will seek insights and suggestions to explore pathways to engage the public with our research outcomes.  Additionally, we will engage with relevant charity networks, such as Neighbourhood Network and OSPREY, to conduct talks, seminars, and events specifically tailored to our target audience. In addition to this, our study’s participants will receive free access to the C2HB app, which offers a wealth of exercise, nutritional, and educational resources.

 

Section 3 - Purpose of research

Purpose of research:

Aim:
This study will examine the effectiveness of digital delivery (C2HB) of a 6-month bespoke osteogenic exercise programme on improving bone density amongst peri- and post-menopausal women.
Objectives:
Objectives include evaluating engagement with the C2HB app and the clinical effectiveness of the osteogenic exercises as quantified with bone turnover biomarkers (P1NP, CTX), bone/muscle health and falls/fractures.
O1. To quantify the effects of exercises on bone remodelling using biomarkers for bone turnover, as well as assess bone density using the gold standard dual-energy X-ray absorptiometry scanner (DXA);
O2. To monitor participant’s completion rates and adherence to the programme within C2HB app;
O3. To enhance the C2HB app, we will incorporate user experience feedback following the programme’s completion;
O4. To develop Healthy Bones website.
O5. To evaluate the effects of exercise for self-reported quality-of-life outcomes;
O6. To monitor participant vitamin D level;
O7. To monitor any falls and fractures.
Deliverables:
1. Research findings report: A comprehensive report summarising the study’s findings, including clinical effectiveness of the exercises, and the impact on bone health in peri- and post-menopausal women.
2. C2HB app usage metrics and enhancement: A detailed analysis of app engagement data and user feedback. This information would provide insights into the effectiveness of the digital delivery of the exercise programme and user acceptance and will be used to enhance the app.
3. Healthy Bones website: The website will empower individuals to make informed decisions about their bone health, while also promoting the use of the C2HB app. Ultimately, this deliverable will contribute to improved awareness, education, and prevention of Osteoporosis-related issues amongst menopausal individuals.
4. Recommendations and guidelines: Recommendations and guidelines for healthcare professionals based on the study’s findings, suggest best practices for utilising digital delivery of osteogenic exercise programmes to improve bone health in peri- and post-menopausal women.

Section 4 - Background to investigation

Background to investigation:

Women experiencing menopause are at risk of reduced bone health due to the natural age-related decline of oestrogen (3). Low bone mineral density (BMD) may lead to osteoporosis. The number of people with osteoporosis is steadily increasing because of the aging population in the UK. Osteoporosis currently affects 3.5 million people (mostly women) in the UK (4), leading to fractures that cost the healthcare system around £4 billion per year (5). Hip osteoporotic fractures have led to mortality rates of 20–24% within the first year after fracture, and the death rate steadily increases for at least the next 5 years (6). Load-bearing exercises are often employed as a great strategy to strengthen the bones, attenuate the rate of decline of BMD and prevent bone fractures in the event of an accident (7).

A balanced diet and progressive resistance training, are important non-pharmacological interventions for improving overall physical function and reducing the risk of falls and fractures (8). It should be emphasised that lifestyle choices, including exercises, significantly impact 20-40% of peak bone mass in adults (9).  Therefore, optimising lifestyle factors that influence peak bone mass and strength is crucial for reducing the risk of osteoporosis in the elderly (9).

Recent systematic reviews and meta-analyses have demonstrated the positive impact of resistance training and weight-bearing exercise modalities on bone density in postmenopausal women (10–12). However, there remains a lack of consensus regarding the optimal frequency, intensity and duration of these exercises, highlighting an area that requires further investigation.

Research has shown that high-intensity resistance and impact training (HiRT) is safe and effective in improving bone health, functional capacity, and body stature in postmenopausal women with low bone mass (13,14). In a six-month intervention involving two weekly sessions of HiRT, significant improvements were observed in lumbar spine BMD (2.8%, P ≤ 0.001) and femoral neck BMD (2.6%, P ≤ 0.004) compared to low-intensity exercise interventions (14).

Osteogenic exercise can also influence bone turnover biomarkers (13), which reflect the rate of bone remodelling. Menopausal women may exhibit elevated bone resorption markers (CTX), indicating increased bone breakdown. Resistance training has been shown to reduce bone resorption markers while simultaneously increasing bone formation markers (P1NP). This suggests that exercise not only preserves bone density but also improves bone quality by balancing bone turnover in favour of bone formation (13).

To comprehensively evaluate the effectiveness of the exercises on bone health, the Gold standard measurement of bone mineral density DXA should be incorporated for specific skeletal locations susceptible to fracture alongside the assessment of bone turnover markers. This combined approach provides a holistic understanding of exercise efficacy and its impact on overall bone mineral density and rate of remodelling.

Our proposed research extends on our recent research conducted at the University of XXXX (14–16) which investigated the relationships between gait characteristics, BMD and mechanical loading of high-impact exercise in postmenopausal women. This research made evidence-based recommendations for osteogenic exercises, which were investigated further through a recent feasibility study in collaboration with a local charity Neighbourhood Network.  A group of 15 healthy peri-menopausal women, who presented with ≥2 risk factors for osteoporosis, and who did not meet the national guidelines for physical activity (i.e. <150 minutes of moderate physical activity/week), were invited to join the Healthy Bones programme. The group participated in a 20-week exercise programme (two weekly group sessions) focusing on resistance and high-impact exercises. A comparison of the baseline to post-intervention data using paired t-test method revealed improvement in the following parameters:

• Handgrip (kg) – baseline (M = 25.2, SD = 4.1), post-intervention (M = 27.2, SD = 4.7), t(11) = 2.15, (P = 0.0005);
• Muscle mass (kg) – baseline (M = 19.2, SD = 2.5), post-intervention (M = 20.1, SD = 2.6), t(11) = 2.14, (P = 0.0002
• Fat free mass (kg) – baseline (M = 43.4, SD = 5.0), post-intervention (M = 44.1, SD = 5.1), t(11) = 2.14, (P = 0.0009);
• Lower limb extensor torque (quadriceps) (N.m) – baseline (M = 99.7, SD = 25.2), post-intervention (M =103, SD = 26.9), t(11) = 2.20, (P = 0.05)
• Flexor (hamstring) torque (N.m) – baseline (M = 37.5, SD = 14.7), post-intervention (M = 45.5, SD = 12.1), t(11) = 2.21, (P = 0.04)
• Maximum knee joint power (W/kg) – baseline (M = 54, SD = 17.7), post-intervention (M = 65.3, SD = 22.1), t(11) = 2.20, (P = 0.02).

While the results proved the feasibility of the programme. The implementation of this exercise programme has revealed potential challenges due to its associated costs of delivery and scheduling flexibility for high attendance. Consequently, a substantial portion of the target population may be unable to participate due to financial constraints. We also noted that some women were unable to attend some of the sessions due to their busy lifestyles. Moreover, intervention studies frequently fail to provide practical implications and guidance to participants following the conclusion of the programme or study (17).

To address these concerns, our aim with the C2HB app is to establish a community that connects women of similar age and interests, providing them with an affordable osteogenic exercise programme to promote bone health and ultimately enhance their overall quality of life. This initiative has the potential to encourage healthier lifestyles and support the aging population, consequently alleviating the burden on healthcare systems.

Section 5 - Plan of investigation

Plan of investigation:

In brief: We aim to recruit 50 women who do not meet the NHS/government physical activity guidelines, are aged 40-55 years old, and present with higher risk of lowering BMD levels.

We will use a randomised controlled trial (RCT) design informed by CONSORT guidelines with two trial arms: an intervention group (n=25) will engage in the 6-month digital C2HB exercise programme, while a control group (n=25) will continue their normal daily activities.

Bone turnover biomarker rate, lumbar spine bone mineral density (BMD), Femoral neck BMD, lower limbs extensor/flexor muscle strength, body composition, height, vitamin D levels, number of falls/fractures (self-reported), menopause symptoms and quality-of-life (using the Menopause-specific Quality of Life (MENQOL) questionnaire (18)) will be measured at baseline and after the 6-month intervention.

Primary outcome: Continuous and two-tailed significance (P1NP and CTX biomarkers). We have used the predicted results for P1NP (an indicator of bone formation) (13), to determine our sample size according to Florey (1993) (19) and include an additional 10% for participant attrition.

Study Parameters
Population mean in  Group 1 (μ1)	32 (μg/L)
Population mean in  Group 2 (μ2)	39 (μg/L)
Type I error (α)	0.05
Power (β)	0.8
Population variance (SD) (σ)	27.9 (g/L)

 

Sample Size (n)
Group 1	25
Group 2	25
Total	50

Activity 1: Researchers, clinicians, and public advisory group (PAG) meeting – (length: single half-day meeting)

Three consultation sessions will be held at the beginning (month 1), midpoint (month 6), and conclusion (month 12) of the study to discuss and plan the project outcome’s delivery to the public.

Activity 2: Participant Recruitment (length: 1.5 months)

Recruitment will be facilitated through existing networks: local partner charity Neighbourhood Network and the University’s Menopause Network.

The inclusion criteria are:

1. Otherwise healthy peri to post-menopausal women aged 40-55 years who do not meet the following criteria:

• Engage in 150 minutes of moderate-intensity aerobic physical activity per week; and/or
• Engage in 75 minutes of vigorous-intensity aerobic physical activity per week; and/or
• Engage in muscle-strengthening activities that involve all major muscle groups 2 days a week.

2. Have access to an iOS device;

3. Willing and able to engage in moderate intensity exercise.

The exclusion criteria are:

1. Current use of medications likely to cause bone loss or use within 5 years prior to study enrolment;
2. Current use of prescription medication that protects bones, or use within 5 years prior to study enrolment (excluding HRT);
3. Neurological disease; recent cardiovascular and/or cerebrovascular event; life-limiting illness;
4. Any individual who has received medical advice to refrain from exercising.

Activity 3: Baseline data collection (length: 1.5 months)

Participants will attend the on-campus Human Performance lab to measure BMD, muscle strength, body composition, and height. All necessary equipment is available in this location. Blood samples will also be taken on-campus under controlled conditions by a trained phlebotomist. Activities 2 and 3 overlap intentionally for efficient data collection (see Figure 3).

Activity 4: Exercise programme (length: 6 months)

Access to C2HB App: Participants will receive access to our new C2HB app (see figure 2), along with necessary equipment e.g. resistance bands and mobile stands (for convenient positioning of smart devices during exercises) during an on-campus induction day.

C2HB App: The app will provide users with nutritional information, a progressive osteogenic exercise programme while also collecting and reporting data on their daily, weekly, and monthly progress. The app further incorporates WhatsApp integration to foster camaraderie and facilitate a sense of community amongst its users. Additionally, the app will gather information on user satisfaction after each exercise session as well as the app’s user interface (UI) and user experience (UX). We will be able to access this data via our cloud-based admin portal. This data can be conveniently exported into a .csv file format for subsequent in-depth analysis.

The exercise programme: The exercise programme includes progressive medium to high-intensity resistance and impact training. It consists of three phases: beginners, intermediate, and advanced, each lasting 8 weeks. Throughout the 24-week duration, there will be a progressive increase in intensity facilitating a smooth transition to the subsequent level and stimulating bone remodelling.

To enhance participants’ adherence to the programme, each session includes a fun exercise component. Participants are encouraged to choose a minimum of two days per week to engage with the exercises. However, they have the flexibility to opt for more than two days of exercise if they prefer to do so.

Activity 5: Focus group meeting 1 (length: single half-day meeting)

A focus group will be conducted on-campus to gather insights that will be utilised to enhance the app’s UI/UX and to facilitate the development of Healthy Bones website.

Activity 6: Development of the Healthy Bones website (length: 4 months)

The website will offer well-researched, evidence-based content on menopause-related bone health. It will seamlessly integrate with the C2HB app, directing visitors to download and use the app for an interactive approach. Website infrastructure preparation starts one month before activity 5 to ensure it is ready for construction.

Activity 7: Post intervention data collection (length: 1.5 months)

Same as activity 3.

Activity 8: Focus group meeting 2 (length: single half-day meeting)

Same as activity 5.

Activity 9: Data analysis (length: 2.5 months)

Paired t-test (parametric) or Wilcoxon signed-rank (non-parametric alternative) test will be used to measure the effectiveness of the programme. NVivo will be used to systematically analyse the qualitative data.

Activity 10: C2HB App enhancement (length: 4 months)

Enhancements will be implemented to improve both UI and UX of the app.

 

Opportunities:

The C2HB app holds opportunity for both clinical adoption and commercial exploitation. After thorough evaluation, the app can potentially be released to the wider public on app stores or offered to healthcare providers for utilisation with similar cohorts, expanding its reach and impact.

Risks:

It is important to note that, based on our understanding, there are currently no direct competitors in the market. However, it is crucial to consider that other competitors could potentially enter the market before us. This emphasises the relevance of the timeliness of our study.

Section 6 - Research environment and resources

Research environment and resources:

The C2HB app has already been developed and is ready for testing.

Access to Allam Diabetes Centre which supports metabolic bone disease research and expert clinicians from the local XXX University Teaching Hospitals provides valuable expertise. These professionals can contribute clinical insights and support in research design and implementation.

The presence of a University-based lab phlebotomist and expert technician ensures efficient and accurate blood sample collection, processing, and analysis. Their expertise adds credibility and reliability to the research findings.

The inclusion of a Human Performance laboratory, along with an expert technician, allows for the assessment of various physiological and performance measures relevant to our research. This facility includes advanced equipment such as the Biodex Isokinetic Dynamometer (for muscle strength measurements) and an in-house DXA scanner.

The availability of a state-of-the-art gym within the University offers an ideal setting for data gathering and initiation of interventions.

The research team comprises of academic experts, and clinical professionals with extensive experience in bone health-related research. This multidisciplinary approach ensures a comprehensive and well-rounded perspective throughout the project.

Collaboration with Menopausal Network and Local Charities: The research group is well-connected with the University’s menopausal network and local charities, including Neighbourhood Network and OSPREY. This collaboration provides access to a diverse and eligible pool of participants, enhancing the study’s generalisability and participant recruitment efforts.

This research has previously received support from the Ideas Fund/Wellcome Trust and the Higher Education Innovation Fund (HEIF) and is currently well-positioned to receive additional funds from the XXX University Impact and Knowledge Exchange (HIKE) Acceleration schemes such as Challenge Fund and Confidence in Concept.

Together, these components create a robust research environment that combines clinical expertise, specialised facilities, cutting-edge technology, and a strong research team. This setting maximises the potential for impactful research outcomes in the field of bone health.

Section 7: Research impact

Who will benefit from this research?

This research aims to have a significant impact by actively involving the public throughout the project. The primary beneficiaries of this research will be peri to post-menopausal women within the local community. The findings and interventions developed for this cohort will serve as a foundation for expanding the research to a national and international level, once the credibility of the C2HB intervention has been established. Additionally, future directions will involve extending the benefits of this research to younger and older age groups through customised preventative and bone-building exercises tailored to their specific needs. Ultimately, the lessons learned from this research can be applied to prevent both Osteoporosis and Sarcopenia. The research will thus have a broad impact on various populations, with the potential to improve the health and well-being of individuals nationally.

How can your research be translated in real-life?

Our research on C2HB aims to have tangible real-life implications by establishing it as an educational and training hub, utilising exercise as a form of medicine. Through this approach, we seek to translate our findings into practical applications that can directly benefit individuals. We envision developing a Healthy Bones Website tailored for menopausal women, particularly focusing on educating them about bone health during and beyond menopause. This platform will serve as a valuable resource, providing evidence-based information, exercise guidelines, and recommendations to enhance bone health and prevent osteoporosis. By actively engaging with clinical experts and the public, we aim to ensure the widespread dissemination and implementation of our research outcomes. Through these efforts, our research will have a direct impact on promoting bone health, improving quality of life, and empowering individuals to make informed decisions regarding their well-being.

How will your research be beneficial for ORUK and its purpose?

Our research on improving bone health during menopause directly aligns with the mission of ORUK to create a healthy aging society and reduce the impact of musculoskeletal dysfunction and osteoporosis on individuals and the NHS. Osteoporosis-related fractures have substantial negative consequences on health and work performance (5). Through the utilisation of digital technology, our research has the potential to reach a broader demographic of women across the nation and internationally, providing them with valuable resources and interventions to enhance bone health, decrease fracture risk, and improve overall well-being. The outcomes of our research will contribute to reducing the burden on the NHS by preventing fractures and minimising the need for expensive treatments. Moving forward, we anticipate exploring commercialisation to address bone and musculoskeletal-related issues, further expanding the impact of our research in accordance with the goals of ORUK.

Section 8: Outreach and engagement

Outreach and engagement play a crucial role in our research, and we have implemented various strategies to promote bone health recommendations and practices. We have established partnerships with local health organisations and community groups, working closely with renowned charities such as Neighbourhood Network and OSPREY as well as our University’s Menopause Network. Through these collaborations, we aim to disseminate valuable information on bone health during menopause to a wider audience.
To enhance engagement we are developing a Healthy Bones Website specifically designed for menopausal women. This platform will serve as an educational resource, providing detailed information on various aspects of bone health during menopause. By utilising digital technology (C2HB app), we aim to reach individuals _Pat a larger scale and enable them to access evidence-based knowledge and recommendations.
Moreover, we prioritise public engagement in our research by providing opportunities for individuals to actively participate and influence the outcome measures in our study that are relevant and important to them. We believe in the power of co-production and collaboration with the public, ensuring that our research is meaningful and aligned with their needs and perspectives.
By partnering with Allam Diabetes Centre, XXX University Teaching Hospitals, charities and community groups, as well as through the development of ‘Healthy Bones’ Website, we seek to extend our research findings beyond academia and directly impact the broader community. Our goal is to empower individuals with knowledge, encourage healthy practices, and facilitate a sense of ownership in the research process.
Through ongoing outreach efforts and effective engagement strategies, we aim to bridge the gap between research and practice, ensuring that our findings are translated into meaningful outcomes that positively impact bone health during menopause. We remain committed to fostering collaborative relationships and actively involving, the public in our research journey.
Overall by nurturing strong partnerships, leveraging digital platforms, and embracing user-centred approaches, our outreach and engagement efforts will contribute to creating a wider understanding of bone health during menopause and empower individuals to make informed decisions about their well-being.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£0

Salary
£0

Consumables
£300

Publications
£0

Conference attendance
£0

Other items
£49665

Total 'requested fund'
£49965



Other items
Category Description Cost to Funder (£) Other Directly Incurred Healthy Bones Website development £6,000.00 Other Directly Incurred DXA scans: (£70 per session x 2 tests x 50 participants) + 10 additional tests for contingency £7,700.00 Other Directly Incurred C2HB App Enhancement £8,000.00 Other Directly Incurred Biomarkers (P1NP: £52 per person - CTX: £25 per person) (2 tests x 50 participants) + 10 P1NP and 10 CTX contingency £8,470.00 Other Directly Incurred Mobile Stand and holder (£36.2 x 25 items) £905.00 Other Directly Incurred The participants' travel expenses cover four visits to the campus for data collection and focus group meetings. £2,500.00 Other Directly Incurred Resistance bands £500.00 Other Directly Incurred Vitamin D (£69 per person x 2 tests x 50 participants) + 10 additional tests for contingency £7,590.00 Professional Services Phlebotomist (£80 per sample x 2 tests x 50 participants) £8,000.00



Other secured funds

Internal funding
£0

Partner (University)
£53889.63

Partner (Commercial)
£0

Partner (Charity)
£0

Other sources
£0

Total 'other funds)
£53889.63

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
No

Who owns and maintains this patent?


Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?