Clinical trial NCT02523274: Resveratrol and Exercise to Treat Functional Limitations in Late Life
Official title: Resveratrol and Exercise to Treat Functional Limitations in Late Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Alabama at Birmingham
First posted: 2015-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the effects of combining physical exercise with a resveratrol supplementation on the physical function of older adults.

Detailed description: This investigation is a pilot study to investigate the potential of resveratrol, a commercially-available nutritional product, to enhance the efficacy of physical exercise in improving physical function among older adults with functional limitations. The overarching objective of this project is to evaluate the safety and efficacy of an intervention combining resveratrol supplementation and physical exercise among sedentary persons aged \> 65 years objectively-measured functional impairments. A total of 60 participants will be recruited to participate in this three month intervention study. All participants will engage in a center-based exercise program 3/days per week and will be randomly assigned to consume 1) placebo, 2) 500 mg/day resveratrol, or 3) 1000 mg/day resveratrol. This study will provide critical information regarding the influence of the combination of resveratrol and exercise on objectively-measured and self-assessed indices of physical function. The study will also provide novel biologic information regarding the relative effects of the interventions on skeletal muscle mitochondrial function.

Eligibility criteria: Inclusion Criteria:

* Ability to understand study procedures and to comply with them for the entire length of the study
* Willingness to be randomized into either treatment group
* Age 65 years and older
* Physical limitations evidenced by \>290 seconds needed to complete long-distance corridor walk test
* Sedentary lifestyle, defined as \<150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire

Exclusion Criteria:

* Failure to provide informed consent
* Regular consumption of a resveratrol supplement
* Current involvement in supervised rehabilitation program
* Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
* Pain classification \> Grade 3 on Graded Chronic Pain Scale
* Peripheral vascular disease; peripheral neuropathy; retinopathy
* 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

* Myocardial infarction or stroke within past year
* Significant cognitive impairment, including:

known dementia diagnosis or a Mini-Mental State Examination exam score \<24

* Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
* Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
* Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
* Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.
* Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
* Simultaneous participation in another intervention trial

Primary outcomes:
measure: Walking Speed
timeFrame: Change at Baseline to 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB).
timeFrame: Change between baseline to 12 weeks
measure: Isokinetic Strength.
timeFrame: Change between baseline and 12 weeks
measure: 6-minute Walk Test
timeFrame: Change between Baseline and 12 weeks
measure: Late-Life Function and Disability Instrument
timeFrame: Change at Baseline to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Center for Exercise Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Thomas Buford, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Stephen Anton
role: PRINCIPAL_INVESTIGATOR
References: