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Completed

NCT Number: NCT02523274

Resveratrol and Exercise to Treat Functional Limitations in Late Life

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UAB Center for Exercise Medicine

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Drug

Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Placebo

Drug

Vegetable-based cellulose

Exercise

Behavioral

Multi-modal exercise regimen, 3 days/week

Primary outcomes

  1. Walking Speed

    Time frame: 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 outcomes

  1. Short Physical Performance Battery (SPPB).

    Time frame: 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.

  2. Isokinetic Strength.

    Time frame: 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.

  3. 6-minute Walk Test

    Time frame: 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.

  4. Late-Life Function and Disability Instrument

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of Alabama at Birmingham

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2015
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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