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Resistance Training and Neuroimaging (RTNI)

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ClinicalTrials.gov Identifier: NCT03982550
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Southern California Clinical and Translational Science Institute
Information provided by (Responsible Party):
Todd Schroeder, University of Southern California

Brief Summary:

Aging tends to compromise the ability to solve problems, remember details, and process information. At the extreme level, this normal cognitive decline can interfere with independent living. Because most brain dysfunctions become irreversible before patients show clear signs in the clinic, there is a pressing need to prioritize preventative countermeasures. Exercise is a promising strategy to slow or reverse these losses. While most studies have looked at running or cycling exercise, little is known about the effects of weight lifting exercise. In addition, vascular health is intimately linked with cognitive abilities and risk of stroke, making it a primary target for intervention. Previous weight lifting studies suggest that blood vessels in the brain are a likely site of adaptation.

The goal of this research is to understand how weight lifting exercise improves cognitive function in older adults. Specifically, the contribution of blood vessel changes in the brain after 12 weeks of weight lifting exercise 3 days per week. These vascular improvements may provide the link between physical and cognitive health, while simultaneously reducing the risk of cardiovascular disease and stroke. To determine this, advanced brain imaging techniques will be used to measure blood flow/volume changes in the brain non-invasively. Physical capacity (i.e. strength), body composition (i.e. lean mass, fat mass), and blood markers will also be assessed using standard protocols, and each of these variables will be tested for their relationship with cognitive functions.

Understanding how weight lifting exercise improves cognitive function will support the development of comprehensive treatments targeting overall brain health. With no current cures for dementia, this information will be vital in prescribing exercise for specific patient needs to reducing the risk of dementia and stroke. In addition, the promise of exercise therapies extends beyond the target disease, having further benefits to the well-being of participants. These types of treatments positively impact fundamental aging processes, and thus reduce the risk of all-cause mortality. Even with moderate benefits to a specific disease like dementia, the global impact on healthcare would be substantial.


Condition or disease Intervention/treatment Phase
Cognitive Decline Cerebrovascular Function Behavioral: Periodized Resistance Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: There are two phases in this single-group study: an initial control period and an intervention period. All control periods will take place before the RT intervention to ensure that results are not confounded by detraining effects or long-term cognitive benefits of RT.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cerebrovascular Mechanisms of Cognitive Enhancement After Periodized Resistance Training in Older Adults
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
No Intervention: Control Period
Participants will serve as their own controls. All 12-week control periods will take place before the RT intervention to ensure that results are not confounded by detraining effects or long-term cognitive benefits of RT. In addition, a control period equal in duration to the intervention allows direct within-subjects statistical comparisons, accounting for each participants' baseline and rate of aging - i.e. age-associated cognitive decline and arterial stiffening. Participants will not be monitored, but may be contacted for scheduling.
Experimental: Intervention Period
Participants will perform a periodized and progressive total-body RT program emphasizing development of lower and upper body strength. All 36 training sessions (3 days per week for 12 weeks) will be performed at the CERC, supervised by an exercise specialist. Participants will be encouraged to continue normal activities of daily living and eating routines outside the RT program of the present study. Because this is a proof-of concept study on normal aging, participants may be contacted for scheduling, but will not be monitored outside of training.
Behavioral: Periodized Resistance Training
Mesocycle I (weeks 1-4) will emphasize muscular hypertrophy to develop a muscular and metabolic base for more intense training in later phases. Training bouts will consist of 4-6 resistance exercises with 2-4 sets per exercise and 8-10 repetitions per set. Mesocycles II (weeks 5-8) and III (weeks 9-12) will emphasize strength development. Training bouts will consist of 4-6 resistance exercises with 3-5 sets per exercise, 4-6 repetitions per set, and linear increases in intensity over time. These parameters were chosen to maximize performance on 4-6 repetition maximum (RM) testing post-intervention, according to the principle of specificity - i.e. specific adaptation to imposed demands.The training loads used will be individually progressed in a safe and effective manner, in order to employ a progressive overload/challenge to the neuromuscular system and elicit the greatest training-induced neuromuscular adaptations possible.




Primary Outcome Measures :
  1. Change in Fluid Cognition Composite Score [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    NIH Toolbox Cognition Battery

  2. Change in Cerebral Blood Flow [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Arterial Spin Labeling Magnetic Resonance Imaging

  3. Change in Vascular Compliance [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Arterial Spin Labeling Magnetic Resonance Imaging

  4. Change in Arterial Transit Time [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Arterial Spin Labeling Magnetic Resonance Imaging


Secondary Outcome Measures :
  1. Change in Crystallized Cognition Composite Score [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    NIH Toolbox Cognition Battery

  2. Change in Total Body Strength [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Calculated 1-repetition maximum

  3. Change in Body Weight [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    InBody

  4. Change in Body Fat Percentage [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Dual-energy X-Ray Absorptiometry

  5. Change in Lower Extremity Power [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Margaria Stair Climb

  6. Change in Systolic Blood Pressure [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Cadiovascular Risk Factors

  7. Change in Diastolic Blood Pressure [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Cadiovascular Risk Factors

  8. Change in Heart Rate [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Cadiovascular Risk Factors

  9. Change in Timed-Up-and-Go [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Functional Mobility

  10. Change in Gait Speed [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Functional Mobility

  11. Change in Y-Balance Total Score [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    Functional Mobility

  12. Change in Hippocampal Volume [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    T1-weighted MP-RAGE

  13. Change in White Matter Lesion Volume [ Time Frame: Baseline, after the initial 12-week control period, and after the 12-week intervention period. ]
    T2-weighted FLAIR



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community-dwelling and living independently (without need of assistance).
  • Interest and availability for participation in a 12-week planned RT program at the CERC, including pre- and post- testing.
  • Competency in English sufficient for assessment and training.
  • Able to see and hear sufficiently to participate in RT.
  • Not engaged in any structured exercise training outside of this intervention.
  • Eligible to undergo MRI.
  • Answer NO to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or receive medical clearance from a physician.

Exclusion Criteria:

  • Possible Dementia (score less than or equal to 23 on MMSE).
  • History of known neurological disease (e.g. Epilepsy, Multiple sclerosis, Parkinson disease, Alzheimer's disease), cerebral infarct (e.g. Stroke), or traumatic brain injury.
  • History of known cardiovascular or metabolic disease or chronic illness which may compromise the patient's ability to safely perform the RT program (e.g. coronary artery disease, arrhythmia, asthma requiring an inhaler during exercise), or presently uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg). Patient may be required to provide clearance from a physician at the study team's discretion.
  • Type 1 or Type 2 Diabetes.
  • Changes in chronic pharmacological treatment (e.g. Aspirin, Statins, or ACE inhibitors) or hormone therapy during the intervention period.
  • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular event.
  • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
  • Contraindications against MRI (e.g. metal implants, claustrophobia).
  • Self-report regular heavy RT in the past 6 months (i.e. "strengthening exercises or lifting weights heavy enough that you could not perform more than 15 repetitions in one set").
  • Musculoskeletal injuries interfering with the ability to perform RT or medical conditions for which exercise in contraindicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982550


Contacts
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Contact: Timothy R Macaulay, BS 323-442-2180 tmacaula@usc.edu
Contact: E. Todd Schroeder, PhD 323-442-2498 eschroed@pt.usc.edu

Locations
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United States, California
Clinical Exercise Research Center Recruiting
Los Angeles, California, United States, 90089
Contact: Timothy R Macaulay    323-442-2180    tmacaula@usc.edu   
Sponsors and Collaborators
Todd Schroeder
Southern California Clinical and Translational Science Institute

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Responsible Party: Todd Schroeder, Associate Professor of Clinical Physical Therapy, University of Southern California
ClinicalTrials.gov Identifier: NCT03982550     History of Changes
Other Study ID Numbers: HS-17-00770
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders