A Precision Rehabilitation Approach to Counteract Age-Related Cognitive Declines

NCT03696082 | Terminated

• 1 other identifier: PRO17100528
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. This study will randomize older adults into one of four interventions for a period of 12 months: 1) Aerobic Exercise, 2) Resistance Exercise, 3) Yoga Exercise, 4) Health Education (involves stretching and range of motion activities). This aims of this study will examine whether and how these different types of training interventions exert effects cognitive function, brain structure, biomarkers of brain health and cognition, and physical function.

Conditions

Cognition Disorders; Brain Pathology; Physical Disability; Physical Activity; Aging

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Brain Structure at 6 and 12 months

  Measured used MRI and fMRI tasks.

  Baseline, 6 months, 12 months

Secondary Outcomes (11)

• Change from Baseline Functional Fitness at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Fitness at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Modified Mini-Mental Status Exam at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Auditory Verbal Learning Test at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

Other Outcomes (10)

• Change from Baseline subjective well-being at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Mood at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

• Change from Baseline Self-Efficacy for Physical Activity at 3, 6, and 12 months

  Baseline, 3 months, 6 months, 12 months

Study Arms (4)

Aerobic Activity

EXPERIMENTAL

Moderate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Behavioral: Aerobic Activity

Resistance Training

EXPERIMENTAL

Resistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Behavioral: Resistance Training

Yoga

EXPERIMENTAL

Yoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Behavioral: Yoga

Health Education

EXPERIMENTAL

This involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Behavioral: Health Education

Interventions

Aerobic Activity BEHAVIORAL

Moderate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Aerobic Activity

Resistance Training BEHAVIORAL

Resistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Resistance Training

Yoga BEHAVIORAL

Yoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Yoga

Health Education BEHAVIORAL

This involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.

Health Education

Eligibility Criteria

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

You may qualify if:

• Age 65-80 years.
• Sedentary, which is defined as regular participation over the past 3 months in \<60 minutes per week of moderate-to-vigorous leisure-time or transportation-related physical activity performed in bouts of \>10 minutes.
• Independent ambulation without or with an cane or walking stick.
• Able to walk (with or without assistive device such as a cane or walking stick) a distance of at least 400 meters based on self-report.
• The ability to provide clearance from a physician for participation in the assessments and intervention aspects of this study.
• Ability to provide informed consent.

You may not qualify if:

• Reporting engaging in regular aerobic exercise, resistance exercise, or yoga exercise over the prior 3 months.
• History of stroke, uncontrolled resting hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg), congestive heart failure, recent myocardial infarction, or other contraindications to engagement in moderate-intensity physical activity for at least 10 continuous minutes.
• Incompatibility with the MRI environment (e.g. claustrophobia, metal implants, or body size, etc.)
• Inability to attend the sessions as prescribed.
• Consuming \>1 alcoholic drink per day on \>4 days per week, or current treatment for substance use disorder.
• Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.
• Use of a walker or rolling walker for ambulation.
• SPPB score of \<6 or unable to perform any of the 3 components of the total score \[item score = 0\].
• Inability to complete the 400m walk test; or an unhealthy response to test \[e.g., Systolic blood pressure \>240 or diastolic blood pressure \>115; or a drop in diastolic blood pressure \> 10mm\].
• Depressive symptoms not controlled or treated.
• List the medications that will exclude a participant (e.g., those that may complicate brain imaging, cognitive test, or biomarker testing or interpretation).
• Degenerative neurological condition \[e.g., Parkinson's Disease, multiple sclerosis\].
• Severe respiratory disease \[eg COPD with shortness of breath\], or use of supplemental oxygen.
• Lower limb below or above knee amputation / prosthesis.
• Score of \<85 of the 3MS (Modified Mini-Mental State Exam).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Cognition Disorders; Motor Activity

Interventions

Exercise; Resistance Training; Yoga

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques

Study Officials

• John M. Jakicic, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Fabrisia Ambrosio, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be masked to intervention assignment.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: October 4, 2018
• Study Start: September 1, 2018
• Primary Completion: January 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)