Clinical trial NCT04848038: Combined Exercise Trial
Official title: Differential Effects of Exercise Modality on Cognition and Brain in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Older adults often experience physical decline that can be directly ameliorated by physical activity and exercise. Evidence is building that exercise prevents cognitive decline or delays the onset of debilitating dementia (e.g. Alzheimer's disease) yet, the optimal dose and combination of exercise modalities for promoting brain health, however, remains unknown and essentially untested.

The long-term research goal of this project is to develop and test strategies to support successful aging and prevent Alzheimer's disease. The study will enroll 280 individuals, age 65 to 80 years without cognitive impairment, into a 26-week exercise intervention to test the combined and independent effects of aerobic and resistance training on cognition, brain structure, and physical function. The project will also explore underlying biological mechanisms that may link exercise with brain health.

Participants will be randomized into 1 of 4 groups: flexibility, toning and balance (control), aerobic exercise training, progressive resistance training, or combined aerobic and resistance training. All intervention groups represent the most common modalities of exercise and directly reflect the public health recommendations for aerobic and resistance training. Exercise training will occur in a community setting through the network of Greater Kansas City Young Men's Christian Association. It is hypothesized that 26 weeks of exercise will improve 1) cognitive performance, 2) regional brain volume, 3) cardiorespiratory fitness and strength 4) biomarkers.

This will be the largest study to assess the combined and independent effects of the two most recommended forms of exercise. Demonstrating specific exercise effects on cognitive function and brain health in older adults would have enormous public health implications. The study's results will also impact public health policy and education by providing evidence towards the specific or synergistic effects of aerobic and resistance training on cognition and brain structure. Encouraging the public to adapt more active lifestyles and stimulate the development of effective exercise delivery programs to enhance initiation and maintenance of physical activity interventions is key to increasing the number of quality years of life for America's aging population.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Global Cognition
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Hippocampal volume
timeFrame: Baseline, 12 months
measure: Peak oxygen consumption
timeFrame: Baseline, 12 months
measure: 1-Repetition Maximum
timeFrame: Baseline, 12 months
Other outcomes:
measure: Wechsler Test of Adult Reading
timeFrame: Baseline
measure: Hopkins Verbal Learning Test - Revised
timeFrame: Baseline, 6 months, 12 months
measure: NIH Toolbox Flanker Task
timeFrame: Baseline, 6 months, 12 months
measure: NIH Toolbox Dimensional Change Card Sort
timeFrame: Baseline, 6 months, 12 months
measure: NIH Toolbox Oral Symbol Digit Test
timeFrame: Baseline, 6 months, 12 months
measure: Virginia Cognitive Aging Project Logical Memory
timeFrame: Baseline, 6 months, 12 months
measure: Spatial Relations
timeFrame: Baseline, 26-weeks, 52-weeks
measure: Letter Comparison
timeFrame: Baseline, 6 months, 12 months
measure: Matrix Reasoning
timeFrame: Baseline, 6 months, 12 months
measure: Task Switching
timeFrame: Baseline, 6 months, 12 months
measure: Spatial Working Memory
timeFrame: Baseline, 6 months, 12 months
measure: Stroop Task
timeFrame: Baseline, 6 months, 12 months
measure: Fat Mass
timeFrame: Baseline, 12 months
measure: Lean Mass
timeFrame: Baseline, 12 months
measure: Bone Mass
timeFrame: Baseline, 12 months
measure: Cerebral brain blood flow
timeFrame: Baseline, 12 months
measure: Senior Fitness Test
timeFrame: Baseline, 12 months
measure: Waist to Hip Ratio
timeFrame: Baseline, 12 months
measure: Body Mass Index
timeFrame: Baseline, 12 months
measure: Blood lactate concentration
timeFrame: Baseline, 12 months
measure: MacArthur Scale of Subjective Social Status
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Applied Cognitive Abilities v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Applied Cognitive General Concerns v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function v1.0
timeFrame: Baseline, 6 months, 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 6 months, 12 months
measure: Perceived Stress Scale, 10-item
timeFrame: Baseline, 6 months, 12 months
measure: EuroQol Group Five Dimension Five Level (EQ-5D-5L)
timeFrame: Baseline, 6 months, 12 months
measure: National Health and Nutrition Examination Survey Diet Survey Questionnaire
timeFrame: Baseline, 6 months, 12 months
measure: Mediterranean Eating Pattern for Americans
timeFrame: Baseline, 6 months, 12 months
measure: Barriers Self-Efficacy Scale
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Exercise Self-Efficacy Scale
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Leisure Self-Efficacy Scale
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Physical Activity Self-Regulation Scale, 12-item
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Blood biomarkers
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Fairway
country: United States
facility: University of Kansas Alzheimer's Disease Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eric D Vidoni, PhD
role: PRINCIPAL_INVESTIGATOR
References: