Clinical trial NCT05631106: Lifestyle Interventions for Vitality and Empowerment in Seniors
Official title: Lifestyle Interventions for Vitality and Empowerment in Seniors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Wake Forest University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Lives within 20 miles of the school
* 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:

* Dependent on walking device
* 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

Primary outcomes:
measure: Executive Functioning
timeFrame: Baseline and 12-weeks
measure: Gradual Continuous Performance Test
timeFrame: Baseline and 12-weeks
measure: Functional Magnetic Resonance Imagining
timeFrame: Baseline and 12-weeks
Secondary outcomes:
measure: Brain Derived Neurotrophic Factor
timeFrame: Baseline and 12-weeks
measure: The Physical Activity Enjoyment Scale
timeFrame: Baseline and 12-weeks
measure: Community Health Activities Model Program for Seniors Activity Questionnaire for Older Adults
timeFrame: Baseline and 12-weeks
measure: Basic Psychological Need Satisfaction and Frustration Scales
timeFrame: Baseline and 12-weeks
measure: SF-36 Health Questionnaire
timeFrame: Baseline and 12-weeks
measure: 400 Meter Walk Test
timeFrame: Baseline and 12-weeks
measure: Short Physical Performance Battery
timeFrame: Baseline and 12-weeks
measure: Stroop Test
timeFrame: Baseline and 12-weeks
measure: Symbol Digit Coding
timeFrame: Baseline and 12-weeks
measure: Four-Part Continuous Performance Test
timeFrame: Baseline and 12-weeks
measure: Shifting Attention Test
timeFrame: Baseline and 12-weeks
Other outcomes:
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