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Lifestyle Interventions for Vitality and Empowerment in Seniors

NCT05631106 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-30

No results posted yet for this study

Summary

The goal of this clinical trial is to test a newer type of high intensity interval resistance training in adults 65 years of age or older. The main aims of this study are:

1. To develop study procedures in order to conduct a randomized controlled trial to test the impact of high intensity interval training on cognition in older adults. We will develop procedures for recruitment, screening, data collection, blinded randomization, HIIRT and EA interventions, safety monitoring, and data analyses.
2. To determine the feasibility of using high intensity interval resistance training as an intervention. Feasibility will be shown by; 1) recruiting the target population and meeting our overall patient accrual goal of 30 participants over a 12-week period, 2) achieving an average attendance rate of ≥ 70% of the 24 scheduled sessions in the HIIRT group, 3) at least 80% retention of participants at the final follow-up assessment (week 12), and 4) successful completion of the MRI task (finishing the session with a behavioral accuracy greater than 70%) by at least 80% of participants. Acceptability will be assessed via participants' ratings on a standardized measure of treatment satisfaction and reasons for dropout. Acceptability will be indicated in 2 ways: 70% of the participants report treatment satisfaction on a standard questionnaire, and consistent collection of follow-up data across sites.
3. To examine causal mechanisms and preliminary efficacy. We will examine the relationships among several proposed mediators of the expected treatment effect. We will also examine the mean change and variability of our primary outcomes.

Conditions

  • Cognitive Change

Interventions

BEHAVIORAL

High Intensity Interval Resistance Training

During each group exercise session, the participants will be guided through a 5-minute warm-up, supervised to perform two sets of machine-based leg press, chest press, seated row, and shoulder press exercises at 30% of 1-RM, and guided through a cool-down. Each exercise set will be 40 -seconds in length with instructions to perform as many repetitions as possible followed by a 20-second rest in between sets and a three-minute rest between exercises.

BEHAVIORAL

Stretching, Balance, and Range of motion

The stretching, balance, and range of motion intervention will include a rotating and varied routine of stretching exercises for large and small muscle groups, and activities to improve balance and range of motion. Participants will attend this intervention twice a week with each session lasting 30 minutes.

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-08-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631106 on ClinicalTrials.gov