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

NCT04660825 | Completed

• 1 other identifier: R18-P094
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Osteoporotic Fracture of Vertebra; Postural, Thoracic Kyphosis

Keywords

Resistance band exercise; High intensity; Osteoporosis; DXA; Bone; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Change in AP lumbar spine bone mineral density (g/cm2)

  Baseline measurement and 6 month follow-up measurements

• Change in AP lumbar spine mineral content (g)

  Baseline measurement and 6 month follow-up measurements

• Change in femoral neck bone mineral density (g/cm2)

  Baseline measurement and 6 month follow-up measurements

• Change in femoral neck bone mineral content (g)

  Baseline measurement and 6 month follow-up measurements

• Change in spinal curvature (°)

  Baseline measurement, 3 months and 6 month follow-up measurements

Study Arms (2)

High intensity resistance band exercise

EXPERIMENTAL

Randomly assigned as exercise group, exercise intervention. This will be a progressive exercise programme with the aim being to participate three times per week, one in a group session and two in-home sessions.

Other: A resistance band exercise programme

Non resistance band exercise

EXPERIMENTAL

Randomly assigned non-exercise group

Other: Control

Interventions

A resistance band exercise programme OTHER

A resistance band based exercise programme lasting six months

High intensity resistance band exercise

Control OTHER

Maintained usual physical activity

Non resistance band exercise

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Donghyeon Seo

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Human Biology

Model Details: The study will be a randomised controlled trial of a six-month exercise intervention. Following screening and baseline measurements, participants will be randomly assigned to exercise or control groups, allocated in 2:1 ratio. Randomisation will conducted using computer algorithm. The exercise group will be requested to complete the intervention as detailed below whilst the control group maintain their usual lifestyle. Participants will complete 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.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: December 9, 2020
• Study Start: October 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)