Progressive Strength and Balance Exercise for Fall Prevention in Postmenopausal Women With Osteop… (NCT07685392) | Clinical Trial Compass
CompletedNot Applicable
Progressive Strength and Balance Exercise for Fall Prevention in Postmenopausal Women With Osteoporosis
Mexico46 participantsStarted 2023-01-01
Plain-language summary
Postmenopausal osteoporosis increases the risk of fragility fractures, and falls are a major modifiable pathway leading to fracture. This single-blind randomized controlled pilot trial evaluated whether a supervised progressive strength and balance exercise program reduced fall occurrence compared with a conventional home-based exercise program in postmenopausal women with osteoporosis. Women aged 60 to 80 years with osteoporosis confirmed by dual-energy X-ray absorptiometry were randomly allocated to either a supervised progressive exercise program or a home-based exercise control group and were followed for 6 months. The primary outcome was the proportion of participants with at least one fall during follow-up. Secondary outcomes included incident fragility fractures, functional performance, balance, balance confidence, handgrip strength, gait speed, posturography parameters, adherence, and exercise-related adverse events. Exploratory analyses assessed whether baseline functional measures were associated with fall occurrence during follow-up. This record was submitted retrospectively after completion of participant enrollment and 6-month follow-up.
Who can participate
Age range
60 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria- Postmenopausal women aged 60 to 80 years.
* Diagnosis of osteoporosis confirmed by dual-energy X-ray absorptiometry, defined as a T-score \<= -2.5 at the lumbar spine, total hip, or femoral neck.
* Ability to participate safely in an exercise program as judged by the investigators.
* Ability to understand and follow study instructions.
* Written informed consent provided before enrollment.
* Clinical conditions that precluded safe participation in exercise.
* Severe neurological disorders affecting independent mobility.
* Severe musculoskeletal disorders affecting independent mobility.
* Inability to follow instructions.
* Any other condition judged by the investigators to interfere with the intervention or outcome assessment.
Exclusion Criteria
* Clinical conditions that precluded safe participation in exercise.
* Severe neurological disorders affecting independent mobility.
* Severe musculoskeletal disorders affecting independent mobility.
* Inability to follow instructions.
* Any other condition judged by the investigators to interfere with the intervention or outcome assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.