Development and Evaluation of an Exercise Intervention for Prevention of Vertebral Osteoporosis and Deformity in Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

The Efficacy of a Resistance Band Exercise Intervention to Improve Vertebral Fracture Risk Facts in Post-menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660825
• Other study ID #: R18-P094
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2020
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoporotic fractures of the vertebrae (bones in the back) cause substantial pain and disability. Exercise could help to prevent these fractures by increasing bone strength and improving posture. Unfortunately, not all exercises strengthen bone. Exercises that do work (e.g. heavy weight lifting) are not popular with women at risk of osteoporosis. The investigators will develop a feasible exercise programme that can be done at a community centre or at home, using resistance bands. The investigators will involve women in designing the programme and incorporate strategies to support behaviour change. The investigators will then examine whether the programme improves bone density, posture or muscle strength in eighty women. Half the women, chosen at random, will take up exercise whilst the remaining half act as a control group. The investigators will take bone scans to determine bone density, and measure spinal curvature and strength, before and after the six- month programme. Findings will be useful in making recommendations as to which types of exercise increase spine bone density and will help to design future research on maximising vertebral strength. If significant benefits are seen, the investigators will develop resources such as booklets and videos so that the intervention can be widely available.

Description:

Healthy, post-menopausal elderly women without other conditions restricting them from completing an exercise intervention. Inclusion criteria will be: Aged 60-80 and postmenopausal for at least 5 years, not taking/eligible for osteoporosis medication. Exclusion criteria will be: regular (>once per week) participation in high impact or high load resistance training, any disease or medication that contraindicates exercise or affects bone metabolism, meet UK criteria for pharmaceutical treatment of osteoporosis (will be referred to GP for treatment). The primary outcome measure will be AP lumbar spine (L1-4) BMD, measured by DXA using a GE Lunar iDXA densitometer. Secondary outcomes will include: BMD at femoral neck and lateral BMD of vertebra and hip structural parameters by DXA. Vertebral morphometry and dimensions, and total and regional body composition (bone, fat and lean masses), spinal curvature will be assessed from lateral DXA scans using statistical shape modelling (SSM) and the Cobb angle will be calculated as a measure of kyphosis, previous and current bone relevant physical activity will be assessed using a validated questionnaire, physical performance will be assessed using the Short Physical Performance Battery and functional mobility will be assessed using the Senior Fitness Test (SFT), peak force developed during exercises will be assessed by performing exercise using a resistance band of the current weight instrumented using a spring balance, postural sway will be assessed by measuring the movement of the centre of mass (COM), centre of foot pressure (COP), body segment through force platforms. The intervention group will be asked to take up a six-month programme of muscle strengthening exercises using resistance bands. Exercises will be introduced through group sessions run three times per week, some of which could be substituted by home exercise supported by an exercise booklet and video. The intervention will consist of initial spinal extension and core strengthening exercises to ensure good posture and form (e.g. thoracic spine extension and abdominal exercise avoiding spinal flexion). Exercises that increased BMD will be adapted for resistance bands, initially at low intensity to allow development of good technique. Intensity will be increased gradually by employing bands of greater stiffness until participants can only complete 8 repetitions without a break. Once participants can attain 12 repetitions, intensity will be progressed by using a higher strength band. Participants will be advised in technique and progression at group sessions, to support transition to independent exercise by the end of the study. The intervention will include a behaviour change component that considers capability, opportunity and motivation using the Behaviour Change Wheel framework by using the taxonomy of behaviour change interventions to identify the most appropriate strategies for facilitating behaviour change. The nature of the intervention considers the social and physical limitations to opportunity to exercise, and physical and psychological capability as identified in the qualitative phase by incorporating a group component to exercise and avoiding settings such as a gym. To accord with the practical and environmental factors identified, sessions will be offered at a variety of times of day. Explanations of safety of exercise with low BMD and purpose of the exercises in the group class and booklet/video will underpin knowledge aspects. Participants will be encouraged to be involved in goal setting and action planning. This will be supported using text reminders and motivational messages or other support strategies. Feedback in group sessions will also reinforce reflective motivation. Support and implementation strategies will be continuously reviewed based upon findings in initial participants. The control group will be asked to continue their usual exercise and dietary habits as if they were not participating in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 60-80 and postmenopausal for at least 5 years
• Not taking/eligible for osteoporosis medication

Exclusion Criteria:

• Regular (>once per week) participation in high impact or high load resistance training.
• Any disease or medication or injury that contraindicates exercise or affects bone metabolism.
• Meet UK criteria for pharmaceutical treatment of osteoporosis (will be referred to GP for treatment).

Related Conditions & MeSH terms

• Kyphosis
• Osteoporosis
• Osteoporotic Fracture of Vertebra
• Osteoporotic Fractures
• Postural, Thoracic Kyphosis
• Spinal Fractures

Intervention

Other:
• A resistance band exercise programme
A resistance band based exercise programme lasting six months
• Control
Maintained usual physical activity

Locations

Country	Name	City	State
United Kingdom	Donghyeon Seo	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AP lumbar spine (L1-4) bone mineral density (g/cm2)	Lumbar spine bone mineral density measured by DXA using a GE Lunar iDXA densitometer	Baseline measurement and 6 month follow-up measurements
Secondary	Change in AP lumbar spine bone mineral density (g/cm2)	DXA scan: Measurement of lumbar spine bone mineral density (g/cm2)	Baseline measurement and 6 month follow-up measurements
Secondary	Change in AP lumbar spine mineral content (g)	DXA scan: Measurement of lumbar spine mineral content (g)	Baseline measurement and 6 month follow-up measurements
Secondary	Change in femoral neck bone mineral density (g/cm2)	DXA scan: Measurement of femoral neck bone mineral density (g/cm2)	Baseline measurement and 6 month follow-up measurements
Secondary	Change in femoral neck bone mineral content (g)	DXA scan: Measurement of femoral neck bone mineral content (g)	Baseline measurement and 6 month follow-up measurements
Secondary	Change in spinal curvature (°)	Spinal curvature will be assessed from lateral DXA scans using the Cobb angle as a measure of kyphosis.	Baseline measurement, 3 months and 6 month follow-up measurements
Secondary	Change in chair stand (sec)	Chair stand: Time taken to stand up and sit down as quickly as possible 5 times.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in gait speed (sec)	Timed walk (Gait speed): Time taken to walk 8-feet (2.44metres)	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in balance (sec)	Tandem balance: Ability to balance unsupported for 10 seconds with feet in three different positions (i.e side by side stands [feet together], semi tandem and full tandem).	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in timed up and go (sec)	Timed up and go: Time taken to rise from a chair, walk three metres away, turn and walk back to the chair and sit down again.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in back scratch (cm)	Back scratch: Distance between hands when reaching both arms behind the back: one arm upwards, one down.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in arm curls (rep)	Arm curls: Number of bicep curls that can be completed in 30s with a 2.25kg dumbbell.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in Posture sway (mm)	Postural sway will be assessed by measuring the movement of the centre of foot pressure (COP) using a force platform. Measurements will be repeated 30 seconds in four conditions: eyes open, firm surface eyes closed, firm surface eyes open, compliant surface eyes closed, compliant surface.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in Trunk extensor strength (N)	Trunk extensor strength will be using a handheld dynamometer. Participant will be asked to lie prone on a couch and push upward against the dynamometer which is mounted on a custom built frame. Participants will be allowed three attempts and the maximum force recorded.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in Trunk extensor endurance (sec)	Back endurance in trunk extension will be assess with the participant lying prone. Participants will be asked to lift the upper body off the surface and hold for as long as possible. The time will be recorded.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	Change in peak force (kg)	Peak force developed during exercises will be assessed by performing exercise using a resistance band of the current weight instrumented using a spring balance.	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	A health screening questionnaire	A health screening questionnaire will be used to assess suitability for the study	Baseline measurement
Secondary	A PAR-Q questionnaire	A PAR-Q questionnaire will be used to check readiness to exercise	Baseline measurement, 3 months and 6 months follow-up measurements
Secondary	A CaQ Calcium intake questionnaire	A CaQ Calcium intake questionnaire will be used to estimate dietary calcium	Baseline measurement, 3 months and 6 months follow-up measurements