Combined Exercise Trial

NCT04848038 | Active Not Recruiting DMC

• 1 other identifier: 146904
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The number of older Americans will double in the next 4 decades to nearly 90 million, placing an unprecedented financial and resource burden on the health care system. Exercise has clear and demonstrable physical benefits, but a more precise understanding of how exercise supports cognitive function is essential. Demonstrating definitively that exercise as recommended by public health entities has benefits for cognition would have enormous public health implications, encourage the public to adapt more active lifestyles, and stimulate the development of effective exercise delivery programs.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Global Cognition

  Assessing change in cognitive function from baseline to 12 months. The 6 month measure is being used to assess the trajectory of the change. A comprehensive neuropsychological battery will be used that assesses a global cognition score derived from domains of cognition (e.g. Executive Function, Visuospatial Processing, Episodic Memory, Processing Speed). We will use a second order confirmatory factor analysis (CFA) to estimate the factor loadings between the observed indicators and the first order factors and between the first and second order factors. The CFA will use baseline data to avoid any potential intervention related biases. The primary outcome will be constructed by summing the weighted average (by the estimated first and second order loadings) of the standardized observed scores across the cognitive tests.

  Baseline, 6 months, 12 months

Secondary Outcomes (3)

• Hippocampal volume

  Baseline, 12 months

• Peak oxygen consumption

  Baseline, 12 months

• 1-Repetition Maximum

  Baseline, 12 months

Other Outcomes (39)

• Wechsler Test of Adult Reading

  Baseline

• Hopkins Verbal Learning Test - Revised

  Baseline, 6 months, 12 months

• NIH Toolbox Flanker Task

  Baseline, 6 months, 12 months

Study Arms (4)

Core and Fusion Training

ACTIVE COMPARATOR

150 minutes/week of Core and Fusion exercise, a mix of low impact toning, strengthening, flexibility and balance exercises.

Behavioral: Exercise

Endurance Training

ACTIVE COMPARATOR

Moderate-intensity endurance training such as brisk walking, 150 minutes/week over 3-5 days. Progression based on a set schedule. In addition 0-2 days of Core and Fusion control exercise will also be recommended.

Behavioral: Exercise

Weight Training

ACTIVE COMPARATOR

Progressive resistance training 2 days/week, non-consecutive, of 2 sets (10 - 15 repetitions) of 10 exercises (\~75 minutes/week). Progression based on repetition completion and 1-repetition maximum. In addition 3 days of Core and Fusion control exercise will also be recommended.

Behavioral: Exercise

Combined Endurance and Weight Training

ACTIVE COMPARATOR

Moderate-intensity endurance training such as brisk walking, 150 minutes/week over 3-5 days. Progression based on a set schedule. Progressive resistance training 2 days/week, non-consecutive, of 2 sets (10 - 15 repetitions) of 10 exercises (\~75 minutes/week). Progression based on repetition completion and 1-repetition maximum.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Standard public health exercise recommendations

Also known as: Weight Training, Aerobic Exercise, Progressive Resistance Exercise, Cross Training

Combined Endurance and Weight Training; Core and Fusion Training; Endurance Training; Weight Training

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-80 yrs (inclusive at time of consent).
• Conversant English speaking and reading ability.
• Medical clearance by a health care provider.
• Reliable means of transportation.
• Telephone Interview of Cognitive Status score \> 25 and adjudication of normal cognition based on cognitive test data by a study medical monitor.

You may not qualify if:

• Intention to move out of the area or travel for more than 4 weeks in the next year.
• Use of an assistive device for ambulation.
• Joint pain severe enough to prevent taking walks in community, lifting objects over your head due to pain or restriction of movement, or that is worsened by increasing physical activity.
• Any MRI contraindications or refusal to attempt MRI.
• Treatment for alcohol or substance abuse in the last 2 years.
• Treatment for cancer (other than non-metastatic, localized cancer) in the last 2 years.
• Currently taking insulin.
• Diagnosis of heart disease, heart failure, heart attack, or heart surgery or chest pain with effort in the last 2 years.
• Untreated atrial fibrillation, valve replacements, angioplasty or stent placement in the last 2 years regardless of physician clearance.
• History of major psychiatric illness including schizophrenia (not including general anxiety disorder or depression), multiple sclerosis, Parkinson's, Dementia, mild cognitive impairment, brain injury (traumatic or clinically evident Stroke), or similar, likely to negatively impact cognitive testing.
• Head injury with loss of consciousness for more than a few minutes.
• Change in blood pressure medication in the last 2 months.
• Considered "Active" or engaging in a progressive resistance training 2 or more times a week.
• reported condition likely to compromise ability to safely perform exercise as determined by study medical monitor (e.g. chronic obstructive pulmonary disease, Lupus, end stage renal disease, etc.)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Alzheimer's Disease Center

Fairway, Kansas, 66205, United States

Location

Related Publications (1)

• Clutton J, Montgomery RN, Mudaranthakam DP, Blocker EM, Shaw AR, Szabo Reed AN, Vidoni ED. An open-source system for efficient clinical trial support: The COMET study experience. PLoS One. 2023 Nov 27;18(11):e0293874. doi: 10.1371/journal.pone.0293874. eCollection 2023.

  PMID: 38011138 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eric D Vidoni, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters (psychometrician, exercise physiologist) who perform outcome assessments will be blinded to the participant's intervention group. The study medical monitor and investigators will be unblinded to assist with safety assessments and address safety concerns or adverse events.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to 1 of 4 study arms. Intervention arm include: 1. core and fusion control condition; 2. 150 minutes of endurance training (ET) only; 3. 2 days a week of progressive weight training (WT) only; 4. 150 minutes of ET and 2 days a week of WT. Participants exercise according to allocation for 1 year.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: October 14, 2021
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)