Lifestyle Interventions for Vitality and Empowerment in Seniors

NCT05631106 | Unknown

• 1 other identifier: IRB00024800
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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

Outcome Measures

Primary Outcomes (3)

• Executive Functioning

  Executive Functioning will be operationalized as an index of several computer-based tasks assessing aspects of executive functioning: Inhibition (Stroop Test), Updating (The 4-part continuous performance task), and Switching (Shifting attention task, Symbol Digit Coding).

  Baseline and 12-weeks

• Gradual Continuous Performance Test

  Participants will make continuous responses to target picture stimuli (images of cities among distractor images of mountains). Periodically, a colored border will appear around each location, cuing the participant to attend to either the left or right picture stream. If the currently cued stream differs from their previous focus of attention, the participant will make a saccadic eye movement. At the same time as the color onset, a number will appear at each location. Participants will then make an even/odd discrimination for stimuli appearing at the to-be-attended location.

  Baseline and 12-weeks

• Functional Magnetic Resonance Imagining

  Participants will complete a 60-minute magnetic resonance imagining session during which will acquire a high-resolution anatomical scan, an echo planar image while participants complete the Gradual Continuous Performance Test. This task is a cognitive task designed to measure the neural correlates of moment-by-moment fluctuations in the efficacy of sustained attention and attention shifting readiness, termed attentional flexibility, a resting state scan, and a diffusion tensor imaging to measure white matter tract integrity.

  Baseline and 12-weeks

Secondary Outcomes (11)

• Brain Derived Neurotrophic Factor

  Baseline and 12-weeks

• The Physical Activity Enjoyment Scale

  Baseline and 12-weeks

• Community Health Activities Model Program for Seniors Activity Questionnaire for Older Adults

  Baseline and 12-weeks

• Basic Psychological Need Satisfaction and Frustration Scales

  Baseline and 12-weeks

• SF-36 Health Questionnaire

  Baseline and 12-weeks

Study Arms (2)

Stretching, Balance, Range of Motion

ACTIVE COMPARATOR

Participants will engage stretching, balance, and range of motion exercises 2 days per week for 12-weeks.

Behavioral: Stretching, Balance, and Range of motion

High Intensity Interval Resistance Training

EXPERIMENTAL

Participants will perform resistance training exercises at high intensity intervals 2 days per week for 12-weeks.

Behavioral: High Intensity Interval Resistance Training

Interventions

High Intensity Interval Resistance Training BEHAVIORAL

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.

High Intensity Interval Resistance Training

Stretching, Balance, and Range of motion BEHAVIORAL

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.

Stretching, Balance, Range of Motion

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

MeSH Terms

Interventions

Range of Motion, Articular

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jeffery A Katula, Ph.D

CONTACT

(336) 758-3612; katulaj@wfu.edu

Anthony Sali, Ph.D

CONTACT

(336) 758-4813; saliaw@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: November 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share