Multi-Domain Exercise Program In Older Women (NCT07311265) | Clinical Trial Compass
CompletedNot Applicable
Multi-Domain Exercise Program In Older Women
Brazil108 participantsStarted 2023-03-10
Plain-language summary
The goal of this clinical trial is to learn whether a long-term exercise program can improve physical health and well-being in older women aged 60 years and older who live in the community.
The main questions this study aims to answer are:
* Does taking part in a supervised exercise program lower waist size?
* Does the exercise program improve walking speed, leg strength, and the ability to move safely?
* Does the program improve motivation for physical activity and feelings of support and well-being?
Researchers will compare a Supervised Multi-Domain Exercise Program (intervention group) with Usual Daily Activities (No Structured Exercise) (control group) to see whether the supervised exercise program leads to better physical and psychological outcomes.
Participants will:
* Be randomly assigned to either the exercise program or a control group
* Take part in supervised exercise sessions twice a week for 12 months if assigned to the exercise group
* Complete physical tests, body measurements, and questionnaires about motivation and well-being at the start of the study and after 12 months
Who can participate
Age range
60 Years – 100 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:
* Women aged 60 years or older.
* Living independently in the community.
* Ability to walk independently, with or without assistive devices.
* Medical clearance to participate in physical exercise.
* Willingness to participate in the exercise program for 12 months.
* Signed informed consent form.
Exclusion Criteria:
* Presence of severe cardiovascular, respiratory, neurological, or musculoskeletal diseases that contraindicate physical exercise.
* Cognitive impairment that prevents understanding of the study procedures.
* Participation in structured exercise programs more than twice per week in the last three months.
* Recent fractures or surgeries that limit physical activity.
* Any condition that, in the opinion of the research team, could compromise participant safety or adherence to the protocol.
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.