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Not Yet Recruiting NCT05631106

Lifestyle Interventions for Vitality and Empowerment in Seniors

Conditions: Cognitive Change

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 30
Sponsor: Wake Forest University

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: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.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.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 schoolDoes not plan to travel outside the home geographic area for an extended period during the study participationWilling to provide informed consentWilling to be randomized to either lifestyle intervention groupWilling to complete all study procedures and assessmentsNo contraindications to exerciseCapacity to complete physical exerciseExclusion Criteria:Dependent on walking deviceClaustrophobiaPerforms 30 minutes of moderate intensity exercise three times per week for the previous three monthsJoint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-monthsUncontrolled hypertensionPathological neurological conditionParkinson's diseaseUnstable depression, anxiety, or schizophrenia (medication changes in the past 6 months)Experienced a concussion within the last 6 monthsRespiratory disease requiring oxygenCancer requiring treatmentOsteoarthritisOsteopenia or OsteoporosisBody mass index under 18Muscle wasting diseaseHypertrophic 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 rehabilitationType I or insulin dependent Type II DiabetesAny implanted medical devices that are not compatible with fMRI scans (cardiac pacemaker or implanted cardiac defibrillator (ICD))Metal shavings in eyesFerromagnetic piercings that cannot be taken outTransdermal patches that cannot be removedCerebral aneurysm clip>14 alcoholic drinks in one weekNot 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05631106). StuddyBuddy aggregates publicly available trial information.