efficacy of nutritional supplementation on physical-activity mediated changes in physical functioning older adults at risk for mobility disability (the vive2 study)

Conditions: Sarcopenia

Summary: 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: * stair climb test * body composition * skeletal muscle cross sectional area * isokinetic/isometric peak torque/power * hand-grip strength * nutritional status * quality of life/depressive symptoms expected enrollment: 150 (80 at tufts university (boston, ma, usa), 70 at university of uppsala (uppsala, sweden))

Eligibility criteria:
inclusion criteria: 1. male \& female ≥ 70 yrs 2. community dwelling 3. short physical performance battery ≤ 9 4. willingness to be randomized and come to the laboratory for 6 months 5. body mass index \< 35 6. mini-mental state examination \>=24 7. serum 25 (oh) d (22.5 -50 nmol/l) 8. having obtained his/her informed consent 9. able to complete 400 m walk within 15 minutes exclusion criteria: * • acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician * current regular use (\> 1 per week) of high protein oral nutritional supplements (eg: boost, exceed etc...) * current use of vitamin d supplements, \>800 iu/day * myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure. * upper or lower extremity fracture in previous 6 months. * hemoglobin \< 10 g/dl, estimated gfr \< 30 ml/min/1.73 m2 * uncontrolled hypertension (\>150/90 mm hg). * neuromuscular diseases and drugs which affect neuromuscular function; severe progressive, degenerative neurologic disease * hormone replacement therapy * insulin-dependent diabetes mellitus * milk protein allergy * major surgery in the past 6 months (requiring general anesthesia) * other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia) * excessive alcohol use (\>14 drinks per wk) * participation in moderate intensity physical activity \> 20 minutes/week * inability to communicate due to severe, uncorrectable hearing loss or speech disorder * severe visual impairment (if it precludes completion of assessments and/or intervention) * severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; wheelchair bound * cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., stage 1 cervical cancer) * severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen * severe cardiac disease, including nyha class iii or iv congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina * patient who cannot be expected to comply with treatment, as decided by the principal investigator and study physician. * conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site principal investigator and/or study physician.

Keywords: sarcopenia nutrition vitamin d exercise