An interventional study of Exercise Intervention and Supplement Intervention in Sarcopenia, sponsored by Tufts University. Completed at 2 sites in 2 countries. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.
Exercise Intervention: Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.
Supplement Intervention: Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
Primary Outcome: The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in \<15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.
Secondary Outcome Measures:
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
Acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician
Dietary Supplement: Supplement Intervention
Dietary Supplement: Supplement Intervention
Other: Exercise Intervention
Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.
Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
Time to Walk 400 meters
The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in \<15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.
Time frame: 6-Month
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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