Exercise and Nutrition for Healthy AgeiNg (NCT03649698) | Clinical Trial Compass
RecruitingNot Applicable
Exercise and Nutrition for Healthy AgeiNg
Belgium180 participantsStarted 2018-02-12
Plain-language summary
The aim of this randomized placebo-controlled 5-arm clinical trial is to evaluate the effect of combined anabolic interventions compared to single or placebo interventions on physical performance in community-dwelling (pre)sarcopenic elderly (≥ 65 years) and to determine the underlying mechanisms of action. Important secondary outcome measures are muscle mass, muscle strength, compliance to the interventions (exercise program, protein and omega-3 supplementation) and functional, cognitive and nutritional status.
Who can participate
Age range
65 Years
Sex
ALL
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
. Male or female persons with (pre)sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP): reduced muscle mass without (presarcopenia) or with (sarcopenia) reduced walking speed (≤ 0.8m/s) or muscle strength OR probable, confirmed or severe sarcopenia according to EWGSOP 2.
. 65 years or older;
. Community-dwelling elderly or assisted living;
. In case of one or more positive answer(s) on the health screen for exercise, subjects need approval of their general practitioner to participate in this randomized controlled trial (RCT).
Exclusion criteria
. Impairments/diseases that impose problems to participation in the study;
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.
What they're measuring
1
Change in physical functioning
Timeframe: Measured at baseline, week 12 and week 24.
2
Percentage of participants with change in physical functioning
Timeframe: Measured at baseline, week 12 and week 24.