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Completed

NCT Number: NCT03771417

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lousiana State University, Baton Rouge, Louisiana, United States

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About this study

Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle and cardiometabolic health has increased over the last 20 years, more than 60% of older adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60 years of age or older do not meet the current public health guidelines for aerobic exercise (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse health behaviors contribute to the development of multiple chronic medical conditions commonly afflicting older adults, including type 2 diabetes, cardiovascular disease, sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health. Recent data also suggest that RE combined with moderate intensity AE effectively improves muscle and cardiometabolic health in older adults. However, the impact that RE combined with LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic health.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are capable and willing to give written informed consent, and understand exclusion criteria
  • 65-80 years of age inclusive
  • Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive
  • Physically inactive determined by self-report
  • Stable medical therapy for allowable medications for 30 days defined as:
  • No addition or removal of a medication
  • No change in dosage of a medication
  • Having no life-threatening conditions or diseases
  • Willing to allow researchers to use data, bio-specimens (blood and muscle tissue), and images (e.g., magnetic resonance imaging) for research purposes after study participation is completed
  • At least 2 weeks post-completion of the COVID19 vaccine regimen. a. Acceptable proof of vaccine includes a completed vaccine card and/or letter from a healthcare provider indicating the date that the COVID19 vaccine was completed.

Exclusion criteria

  • Nursing home resident
  • Physically Active:

a. > 100 min/wk of moderate OR > 50 min/wk vigorous intensity PA

  • Saint Louis University Mental State (SLUMS) score < 21
  • Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  • Evidence or self-report history of type 1 or 2 diabetes mellitus
  • Evidence or self-report history of a bleeding disorder
  • Evidence or self-report history of recurrent vasovagal episodes
  • Evidence or self-report history of severe depression, Schizophrenia, bipolar disease
  • Evidence or self-report history of mobility disability requiring a walker, wheel chair, or inability to walk across a small room.
  • Evidence or self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
  • Evidence or self-report history of severe arthritis (either osteoarthritis or rheumatoid arthritis) that would preclude them from participation in a dynamic exercise program
  • Evidence or self-report of history untreated thyroid dysfunction.
  • Weight loss of > 10% in the last 3 months prior to screening
  • History of weight loss surgery.
  • Use of medications known to influence study outcomes, such as:
  • Insulin
  • Oral antidiabetic medications (e.g., metformin)
  • Corticosteroids
  • Beta-blockers

c. Anticoagulants

  • Allergy to lidocaine
  • Active smoking
  • Current consumption of > 14 alcoholic drinks per week based on self-report
  • Regular participation in resistance or aerobic exercise training within 3 months of initial screening
  • Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,16 including:
  • Resting diastolic blood pressure > 100 mm Hg
  • Resting systolic blood pressure > 180 mm Hg
  • Resting heart rate > 100 beats per min
  • Having a body weight greater than 440 pounds
  • Having medical implants such as a pacemaker or metal joint replacements
  • Having tattoos or permanent makeup completed <30 days prior to the visit
  • Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune suppressants
  • Presence of allergies or infections requiring antibiotics within the past 14 days
  • Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities
  • Any other condition that in the judgement of the Principal Investigator and/or the Medical Director of this protocol may interfere with study participation and adherence to the protocol.
  • Evidence or self-report history of severe depression in the last 5 years.

Treatment and study plan

Exercise Intervention

Behavioral

The use of exercise to improve muscle and cardiometabolic health in older adults.

Primary outcomes

  1. Skeletal Muscle Strength

    Time frame: Measured at week 0 (baseline) and week 16

    The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.

  2. Skeletal Muscle Mass

    Time frame: Measured at week 0 (baseline) and week 16

    The investigators will determine the change from baseline in skeletal muscle mass. These measurements will be performed at baseline and following 16 weeks of exercise training using Dual X-Ray Absorptiometry.

Secondary outcomes

  1. Mitochondrial Function

    Time frame: Measured at week 0 (baseline) and week 16

    The investigators will determine the change from baseline in mitochondrial function. These measurements will be performed at baseline and following 16 weeks of exercise training.

Sponsors and collaborators

Lead sponsor

Louisiana State University and A&M College

Other

Collaborators

  • National Institute on Aging (NIA)
  • Pennington Biomedical Research Center

Registry information

Official study title

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Skeletal Muscle and Cardiometabolic Health in Older Adults-REALPA Breaks in Sedentary Time Pilot Study

Acronym: REALPA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2018
Registry last updated
Mar 19, 2025

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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