Resveratrol and Exercise to Treat Functional Limitations in Late Life

Phase 2

Completed

Conditions: Aging

Interventions: Drug: Placebo
Drug: Resveratrol
Behavioral: Exercise

Registration Number: NCT02523274

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + exercise	Placebo	Placebo capsules will be taken orally daily in combination with exercise
Placebo + exercise	Exercise	Placebo capsules will be taken orally daily in combination with exercise
Resveratrol 500 mg/day + exercise	Resveratrol	500 mg/day resveratrol taken orally in combination with exercise
Resveratrol 500 mg/day + exercise	Exercise	500 mg/day resveratrol taken orally in combination with exercise
Resveratrol 1000 mg/day + exercise	Exercise	1000 mg/day resveratrol taken orally in combination with exercise
Resveratrol 1000 mg/day + exercise	Resveratrol	1000 mg/day resveratrol taken orally in combination with exercise

Primary Outcome Measures

Name	Time	Method
Walking Speed	Change at Baseline to 12 weeks	Walking speed is assessed by asking the participants to walk at their usual pace over a 4 m course. Participants are to stand with both feet touching the starting line and to start walking after a verbal command is given, and the time needed to complete the entire distance will be recorded. The faster of two walks will be used and changes between the groups at baseline and 12 weeks will be assessed.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB).	Change between baseline to 12 weeks	Investigators will assess lower-extremity function by asking the participants to perform a series of tasks including: walking at their usual pace over a 4 m course, repeated chair stands, and a balance test. Each task is scored from 0 to 4, with 4 indicating best level of performance and 0 the inability to complete the test. A summary score (0-12) is then calculated. Higher score on the scale is reflective of higher function and lower score reflects lower functioning. Changes between the groups at baseline and 12 weeks will be assessed.
Isokinetic Strength.	Change between baseline and 12 weeks	Isokinetic strength of the dominant limb will be assessed by a standard dynamometer and changes between the groups at baseline and 12 weeks will be assessed.
6-minute Walk Test	Change between Baseline and 12 weeks	Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test to assess change in meters walked between the groups at baseline and 12 weeks.
Late-Life Function and Disability Instrument	Change at Baseline to 12 weeks	The instrument includes 16 tasks representing a broad range of disability indicators that assesses both frequency of doing a task and perceived limitation. The instrument uses a scale from 0 to 100, with higher scores indicating higher levels of function.