Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 6:59 AM
Study NCT ID:
NCT05631106
Status:
UNKNOWN
Last Update Posted:
2022-11-30
First Post:
2022-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Interventions for Vitality and Empowerment in Seniors
Sponsor:
Wake Forest University
Organization:
Study Overview
Official Title:
Lifestyle Interventions for Vitality and Empowerment in Seniors
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIVES
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: