Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)
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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.
Condition | Intervention | Phase |
---|---|---|
Sarcopenia |
Other: Exercise Intervention Dietary Supplement: Supplement Intervention |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study) |
- Time to Walk 400 meters [ Time Frame: 6-Month ] [ Designated as safety issue: No ]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.
Estimated Enrollment: | 150 |
Study Start Date: | October 2011 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Supplement |
Dietary Supplement: 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.
|
Sham Comparator: Placebo |
Dietary Supplement: 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.
|
Experimental: Exercise |
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.
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Detailed Description:
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))
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male & Female ≥ 70 yrs
- Community dwelling
- Short Physical Performance Battery ≤ 9
- Willingness to be randomized and come to the laboratory for 6 months
- Body Mass Index < 35
- Mini-Mental State Examination >=24
- Serum 25 (OH) D (22.5 -50 nmol/l)
- Having obtained his/her informed consent
- 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.
Contact: Dylan R Kirn, B.S. | 617-556-3399 | Dylan.Kirn@tufts.edu |
United States, Massachusetts | |
Jean Mayer Human Nutrition Research Center on Aging at Tufts University | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Dylan R Kirn, B.S. 617-556-3399 Dylan.Kirn@tufts.edu | |
Principal Investigator: Roger Fielding, Ph.D | |
Sweden | |
Uppsala University | Not yet recruiting |
Uppsala, Sweden, 75185 | |
Contact: Tommy Cederholm, MD/PhD 46186117970 | |
Principal Investigator: Tommy Cederholm, MD/PhD |
Principal Investigator: | Roger Fielding, PhD | Tufts University |
No publications provided
Responsible Party: | Tufts University |
ClinicalTrials.gov Identifier: | NCT01542892 History of Changes |
Other Study ID Numbers: | 10.27.CLI |
Study First Received: | February 27, 2012 |
Last Updated: | March 1, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
Sarcopenia Nutrition Vitamin D Exercise |
Additional relevant MeSH terms:
Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical Signs and Symptoms |
ClinicalTrials.gov processed this record on October 17, 2012