NCT03982550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2020

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

June 5, 2019

Last Update Submit

May 18, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Fluid Cognition Composite Score

    NIH Toolbox Cognition Battery

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Cerebral Blood Flow

    Arterial Spin Labeling Magnetic Resonance Imaging

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Vascular Compliance

    Arterial Spin Labeling Magnetic Resonance Imaging

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Arterial Transit Time

    Arterial Spin Labeling Magnetic Resonance Imaging

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

Secondary Outcomes (13)

  • Change in Crystallized Cognition Composite Score

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Total Body Strength

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Body Weight

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Body Fat Percentage

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • Change in Lower Extremity Power

    Baseline, after the initial 12-week control period, and after the 12-week intervention period.

  • +8 more secondary outcomes

Study Arms (2)

Control Period

NO INTERVENTION

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.

Intervention Period

EXPERIMENTAL

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

Interventions

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.

Intervention Period

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Exercise Research Center

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Clinical Physical Therapy

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 11, 2019

Study Start

July 17, 2018

Primary Completion

May 16, 2020

Study Completion

May 16, 2020

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations