Phase 2
N=60
Resveratrol and Exercise to Treat Functional Limitations in Late Life
Aging
Bottom Line
View on ClinicalTrials.gov: NCT02523274 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Jan 2022
Primary outcome: Primary: Walking Speed — -0.04; -0.03; 0.04 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Resveratrol (Drug); Placebo (Drug); Exercise (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Speed |
-0.04; -0.03; 0.04 | — |
| SECONDARY Short Physical Performance Battery (SPPB). |
0.38; 0.25; 0.13 | — |
| SECONDARY Isokinetic Strength. |
-3.24; 10.5; 6.15 | — |
| SECONDARY 6-minute Walk Test |
9.34; 22.9; 33.1 | — |
| SECONDARY Late-Life Function and Disability Instrument |
4.77; 5.72; 3.36 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02523274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.