Dual-benefits of Aerobic and Resistance Training

NCT03978572 | Suspended

• 1 other identifier: 18-F-55
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of three different exercise strategies on physical function in older adults. Participants will be randomly assigned to one of three exercise groups: resistance training, moderate-intensity continuous cycling on a stationary bicycle, and high-intensity interval training on a stationary bicycle.

Conditions

Sarcopenia; Aging; Disability Physical

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• Maximal Oxygen Consumption

  The primary endpoint is maximal oxygen consumption measured by both relative and absolute changes in maximal oxygen consumption obtained during a graded exercise test on a cycle ergometer.

  Change from baseline at 12 weeks

• Knee extensor isokinetic power

  Maximal muscle power (maximal torque in foot-pounds) of the quadriceps using an isokinetic dynamometer

  Change from baseline at 12 weeks

Secondary Outcomes (2)

• Knee extensor isometric force production

  Change from baseline at 12 weeks

• Knee extensor isokinetic endurance

  Change from baseline at 12 weeks

Study Arms (3)

Resistance Training

ACTIVE COMPARATOR

12 weeks of whole-body progressive resistance training, three days per week, lower-extremity focused (60% of exercises targeting lower extremities)

Behavioral: Resistance Training

Moderate-intensity continuous cycling

ACTIVE COMPARATOR

12 weeks of progressive endurance cycling on a stationary bicycle at a target heart rate, three days per week.

Behavioral: Moderate-Intensity Continuous Cycling

High-intensity interval cycling

EXPERIMENTAL

12 weeks of progressive high-intensity interval cycling on a stationary bicycle, three days per week.

Behavioral: High-Intensity Interval Cycling

Interventions

Resistance Training BEHAVIORAL

Exercise intervention designed to improve muscular strength and power

Resistance Training

Moderate-Intensity Continuous Cycling BEHAVIORAL

Exercise intervention designed to improve cardiorespiratory fitness and muscular endurance

Moderate-intensity continuous cycling

High-Intensity Interval Cycling BEHAVIORAL

Exercise intervention designed to improve cardiorespiratory fitness, muscular endurance, and muscular strength and power

High-intensity interval cycling

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-75 years with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
• Body mass index between 18.0 and 35 kg/m2.
• Willingness to maintain current diet and adhere to the intervention programs described for the study and willing to undergo all testing procedures.
• Able to read, understand, and complete study-related questionnaires
• Able to read and understand, and willing to sign the informed consent form (ICF).
• minute walk distance of 450-725 meters for men and 400-675 meters for women.

You may not qualify if:

• Failure to provide informed consent.
• minute walk distance below 450 meters or above 725 meters for men, below 400 meters or above 675 meters for women
• Any activities of daily living (ADL) disability (difficulty feeding, dressing, continence, bathing, toileting, and transferring).
• Lives in a nursing home or assisted living facility
• Known neuromuscular or neurological conditions affecting somatosensory or motor function or control (e.g., hemiplegia, multiple sclerosis, peripheral neuropathy, Parkinsons disease, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, etc.).
• Unable to communicate because of severe hearing loss or speech disorder.
• Severe visual impairment, which would preclude completion of the assessments.
• Cancer requiring treatment currently or in the past 2 years (except primary non-melanoma skin cancer or in situ cervical cancer)
• Hospitalization (medical confinement for 24 hours), or immobilization, or major surgical procedure requiring general anesthesia within 12 weeks prior to screening, or any planned surgical procedures during the study period.
• Chronic or relapsing/remitting gastrointestinal disorders such as inflammatory bowel disease and irritable bowel syndrome.
• Known history of human immunodeficiency virus (HIV) antibody at screening.
• Use of systemic glucocorticoids.
• Any history of angina pectoris
• Any history of heart failure
• Any history of myocardial infarction

Sponsors & Collaborators

• Ohio University: lead
• American Heart Association: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (1)

• Tavoian D, Russ DW, Law TD, Simon JE, Chase PJ, Guseman EH, Clark BC. A Randomized Clinical Trial Comparing Three Different Exercise Strategies for Optimizing Aerobic Capacity and Skeletal Muscle Performance in Older Adults: Protocol for the DART Study. Front Med (Lausanne). 2019 Oct 22;6:236. doi: 10.3389/fmed.2019.00236. eCollection 2019.

  PMID: 31750307 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brian C Clark, PhD

  Ohio University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: February 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)