Cocoa with exercise to boost walking and strength in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 1/2 study enrolls adults aged 55 and older with slow walking speed (<1.0 m/s) and compares structured aerobic plus resistance training combined with an (-)-epicatechin–rich cocoa supplement versus the same exercise program with a placebo. Participants follow supervised exercise sessions and undergo functional testing of walking performance and muscle strength, with optional muscle biopsy for mechanistic studies. The trial targets mitochondrial function and reactive oxygen species pathways as potential biological reasons some people do not fully respond to exercise alone. The study is single-site at the University of Alabama at Birmingham.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 55 years and older
* Slow walking speed of \< 1m/s
* Willingness to be randomized to either treatment group
* Willingness to participate in all study procedures (muscle biopsy will be optional)

Exclusion Criteria:

* Failure to provide informed consent;
* Regular consumption of flavanol and/or cocoa supplements
* Current involvement in supervised rehabilitation/exercise training program
* Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines \[17\]
* Daytime average of systolic blood pressure ≥ 180/100mm Hg.
* Refusal to stop blood thinners such as baby aspirin dose.
* 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;
* 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 months;
* Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
* Simultaneous participation in another interventional trial

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Robert T Mankowski, PhD — University of Alabama at Birmingham
• Study coordinator: Robert T Mankowski, PhD
• Email: rmankowski@uabmc.edu
• Phone: 205-996-3006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.