Lifestyle Interventions for Vitality and Empowerment in Seniors
NCT ID: NCT05631106
Last Updated: 2022-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-11-30
2023-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Stretching, Balance, Range of Motion
Participants will engage stretching, balance, and range of motion exercises 2 days per week for 12-weeks.
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.
High Intensity Interval Resistance Training
Participants will perform resistance training exercises at high intensity intervals 2 days per week for 12-weeks.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Does not plan to travel outside the home geographic area for an extended period during the study participation
* Willing to provide informed consent
* Willing to be randomized to either lifestyle intervention group
* Willing to complete all study procedures and assessments
* No contraindications to exercise
* Capacity to complete physical exercise
Exclusion Criteria
* Claustrophobia
* Performs 30 minutes of moderate intensity exercise three times per week for the previous three months
* Joint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-months
* Uncontrolled hypertension
* Pathological neurological condition
* Parkinson's disease
* Unstable depression, anxiety, or schizophrenia (medication changes in the past 6 months)
* Experienced a concussion within the last 6 months
* Respiratory disease requiring oxygen
* Cancer requiring treatment
* Osteoarthritis
* Osteopenia or Osteoporosis
* Body mass index under 18
* Muscle wasting disease
* Hypertrophic or dilated cardiomyopathy significant cardiovascular disease (NIHA Class III/IV congestive heart failure, aortic stenosis, history of cardiac arrest, uncontrolled angina)
* Currently receiving physical therapy or cardiopulmonary rehabilitation
* Type I or insulin dependent Type II Diabetes
* Any implanted medical devices that are not compatible with fMRI scans (cardiac pacemaker or implanted cardiac defibrillator (ICD))
* Metal shavings in eyes
* Ferromagnetic piercings that cannot be taken out
* Transdermal patches that cannot be removed
* Cerebral aneurysm clip
* \>14 alcoholic drinks in one week
* Not receiving medical clearance after PARQ+
* Evidence of cognitive impairment (Scoring below 32 points on the Telephone Interview of Cognitive Status)
* Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence, clinical judgement
65 Years
ALL
Yes
Sponsors
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Wake Forest University
OTHER
Responsible Party
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Jeff Katula
Professor
Central Contacts
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Other Identifiers
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IRB00024800
Identifier Type: -
Identifier Source: org_study_id