Exercise and Nutrition for Healthy AgeiNg
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 s
| Condition(s) | Sarcopenia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. 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. 2. 65 years or older; 3. Community-dwelling elderly or assisted living; 4. 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). * Uncontrolled or unstable health problems * Uncontrolled pain or feeling unwell the day of the exercise * Recently diagnosed cardiovascular events * systolic blood pressure (SBP) ≥ 180 mmHg and/or diastoli |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Leuven, Vlaams-Brabant, Belgium |
| Start date | 2018-02-12 |
| NCT ID | NCT03649698 |
| Official listing | https://clinicaltrials.gov/study/NCT03649698 |