- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099678
Enhancing Strength Gains With the Power of the Mind
The Effect of Combining Maximal Mental Effort With Elastic Band Training on Strength and Neuromuscular Adaptations in Older Females
The goal of this clinical trial is to determine the effect of maximal mental effort combined with elastic band training on strength and neuromuscular function in healthy, older females. The main questions it aims to answer are:
- Does elastic band training in combination with maximal mental effort increase strength more than elastic band training alone?
- Does elastic band training in combination with maximal mental effort improve neuromuscular function more than elastic band training alone?
Participants will be randomly assigned to 1 of 3 groups:
- Elastic band training
- Elastic band training with maximal mental effort
- Control
Researchers will compare groups to determine differences in changes in strength, neuromuscular function, and body composition.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants in both training groups will perform 6 weeks of moderate intensity, whole-body elastic band training. Participants in the control group will participate in all testing procedures but not perform any training. Participants from both groups will be instructed to maintain their normal physical activity levels and dietary habits.
All training sessions will be home-based and virtually supervised by research personnel. Participants will complete 2 training sessions in the first week and 3 training sessions per week for the remaining 5 weeks. Each training session will last about 45-60 minutes and consist of 7 exercises performed in the same order by each participant, including both multi-joint (chair squat, chest press, leg press, back row) and single-joint (knee extension, knee flexion, elbow flexion) exercises. Participants will perform 12 repetitions for each exercise for the first 3 weeks, then volume will be increased by progressing to 4 sets for the remaining 3 weeks. There will be a 60-second rest interval between sets and a similar tempo will be used between groups.
Both training groups will perform the same training protocol, but participants in the maximal mental effort group will mentally urge their muscles to contract maximally during each repetition. That is, despite using a moderate intensity, participants will imagine the feeling of maximal muscle contraction of the primary muscles during each repetition.
Several measures of strength, neuromuscular function, physical function, and body composition will be measured before and after the training or control period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Garrett Hester, Ph.D.
- Phone Number: 470-578-4267
- Email: ghester4@kennesaw.edu
Study Locations
-
-
Georgia
-
Kennesaw, Georgia, United States, 30144
- Recruiting
- Kennesaw State University
-
Contact:
- Garrett M Hester, Ph.D.
- Phone Number: 470-578-4267
- Email: ghester4@kennesaw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between 65-79 years of age
- Female
- Have not engaged in structured exercise for 3 years
- Are not reliant upon a walking aid
- Be able to rise from a chair unassisted
- BMI between 25-33 kg/m²
- Have access to the internet and access to a smartphone or computer with a camera at home
Exclusion Criteria:
- Any history of cardiovascular, cerebrovascular, or metabolic diseases
- Musculoskeletal injury within the past 6 months
- Any condition affecting muscle function
- Uncontrolled hypertension
- Score less than 23 on the Mini-mental State Exam
- Upon starting study, missing more than 2 training session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Elastic Band Training
This group will perform moderate intensity, whole-body elastic band training.
|
This training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises.
|
|
Experimental: Elastic Band Training with Maximal Mental Effort
This group will perform moderate intensity, whole-body elastic band training with maximal mental effort during muscle contraction.
|
This training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises, where participants will perform maximal mental effort by imagining maximal muscle contraction during each exercise.
|
|
No Intervention: Control
This group will not perform any training and maintain their regular level of physical activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bicep curl strength as measured by load lifted in pounds
Time Frame: Baseline, Week 7
|
Maximum dumbbell load lifted successfully throughout the range of motion of a bicep curl
|
Baseline, Week 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in voluntary activation as measured by ratio of superimposed torque to resting twitch torque
Time Frame: Baseline, Week 7
|
Voluntary activation is an estimate of neural drive and is the amplitude of superimposed torque elicited by percutaneous muscle stimulation relative to the resting twitch torque amplitude
|
Baseline, Week 7
|
|
Change in handgrip strength as measured in kilograms of force
Time Frame: Baseline, Week 7
|
Upper-body strength as measured by a handgrip dynamometer
|
Baseline, Week 7
|
|
Change in agonist muscle activation as measured by electromyography amplitude
Time Frame: Baseline, Week 7
|
A measure of the capacity at which the muscle is activitated by the nervous system
|
Baseline, Week 7
|
|
Change from baseline in isokinetic muscle activation at 6 weeks
Time Frame: Baseline, Week 7
|
Electromyography root mean square during isokinetic contraction divided by root mean square during isometric contraction
|
Baseline, Week 7
|
|
Change in antagonist co-activation as measured by electromyography amplitude
Time Frame: Baseline, Week 7
|
A measure of the capacity at which the antagonist muscle is activated by the nervous system
|
Baseline, Week 7
|
|
Change in isometric bicep strength as measured by newton-meters of torque
Time Frame: Baseline, Week 7
|
Isometric strength of a muscle
|
Baseline, Week 7
|
|
Change in isokinetic bicep strength as measured by newton-meters of torque
Time Frame: Baseline, Week 7
|
Dynamic strength of a muscle contracting at a constant velocity
|
Baseline, Week 7
|
|
Change in rate of torque development as measured by newton-meters per second
Time Frame: Baseline, Week 7
|
A measure of the capacity to increase muscle torque rapidly as determined by the slope of the torque-time curve
|
Baseline, Week 7
|
|
Change in walking speed as measured by time taken to walk 6 meters
Time Frame: Baseline, Week 7
|
Measure of lower-body physical function
|
Baseline, Week 7
|
|
Change in chair rise performance as measured by number of chair rises performed in 30 seconds
Time Frame: Baseline, Week 7
|
Measure of lower-body physical function
|
Baseline, Week 7
|
|
Change in chair rise power by watts by a linear transducer attached to hip during chair rise test
Time Frame: Baseline, Week 7
|
Product of load and velocity as determined on a linear transducer
|
Baseline, Week 7
|
|
Change in muscle composition as measured by ultrasound-derived grey-scale analysis
Time Frame: Baseline, Week 7
|
Echo-intensity value derived from grey-scale analysis is indicative of amount of non-contractile tissue in muscle
|
Baseline, Week 7
|
|
Change in skeletal muscle size as measured by ultrasound-derived cross-sectional
Time Frame: Baseline, Week 7
|
Size of a muscle
|
Baseline, Week 7
|
|
Change in fat mass as measured by kilograms
Time Frame: Baseline, Week 7
|
Amount of fat tissue a person possesses estimated by bioelectrical impedance analysis
|
Baseline, Week 7
|
|
Change in fat-free mass as measured by kilograms
Time Frame: Baseline, Week 7
|
Amount of non-fat tissue a person possesses estimated by bioelectrical impedance analysis
|
Baseline, Week 7
|
|
Change in body fat percentage as measured by fat tissue relative to fat-free tissue
Time Frame: Baseline, Week 7
|
Relative amount of body fat a person possesses estimated by bioelectrical impedance analysis
|
Baseline, Week 7
|
|
Change in hemoglobin A1c level as measured by blood drop analysis
Time Frame: Baseline, Week 7
|
Blood drop analysis, obtained from fingerstick, measure of amount of blood sugar bound to hemoglobin
|
Baseline, Week 7
|
|
Change in resting heart rate as measured by beats/min using oscillatory cuff
Time Frame: Baseline, Week 7
|
Measure of cardiovascular fitness
|
Baseline, Week 7
|
|
Change in resting blood pressure in millimeters of mercury using oscillatory cuff
Time Frame: Baseline, Week 7
|
Measure of cardiovascular fitness
|
Baseline, Week 7
|
|
Change in general feeling about knee extension and bicep curl exercise
Time Frame: Each exercise session of the 6-week intervention
|
From a -5 to +5 on the Affective Feeling Scale
|
Each exercise session of the 6-week intervention
|
|
Change in grip width on elastic band as measured by distance of hand placements on band
Time Frame: Baseline, 3 weeks, 5 weeks
|
Indication of progression in training intensity
|
Baseline, 3 weeks, 5 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in exercising heart rate
Time Frame: Each exercise session of the 6-week intervention
|
A descriptor of the exercise physiological intensity for both training protocols
|
Each exercise session of the 6-week intervention
|
|
Change in calorie consumption as measured by kilocalories determined by dietary recall
Time Frame: Baseline, Week 7
|
Amount of calories consumed
|
Baseline, Week 7
|
|
Change in protein consumption as measured by kilocalories determined by dietary recall
Time Frame: Baseline, Week 7
|
Amount of protein consumed
|
Baseline, Week 7
|
|
Change in physical activity as measured by daily step count via Garmin Venu SQ smartwatch
Time Frame: Baseline, Week 7
|
Measure of physical activity level
|
Baseline, Week 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Garrett Hester, Ph.D., Kennesaw State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-Harper
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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