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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06099678
Other study ID # 2024-Harper
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date November 1, 2024

Study information

Verified date December 2023
Source Kennesaw State University
Contact Garrett Hester, Ph.D.
Phone 470-578-4267
Email ghester4@kennesaw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date November 1, 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Elastic Band Training
This training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises.
Elastic Band Training with Maximal Mental Effort
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.

Locations

Country Name City State
United States Kennesaw State University Kennesaw Georgia
United States Kennesaw State University Kennesaw Georgia

Sponsors (1)

Lead Sponsor Collaborator
Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in exercising heart rate A descriptor of the exercise physiological intensity for both training protocols Each exercise session of the 6-week intervention
Other Change in calorie consumption as measured by kilocalories determined by dietary recall Amount of calories consumed Baseline, Week 7
Other Change in protein consumption as measured by kilocalories determined by dietary recall Amount of protein consumed Baseline, Week 7
Other Change in physical activity as measured by daily step count via Garmin Venu SQ smartwatch Measure of physical activity level Baseline, Week 7
Primary Change in bicep curl strength as measured by load lifted in pounds Maximum dumbbell load lifted successfully throughout the range of motion of a bicep curl Baseline, Week 7
Secondary Change in voluntary activation as measured by ratio of superimposed torque to resting twitch torque 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
Secondary Change in handgrip strength as measured in kilograms of force Upper-body strength as measured by a handgrip dynamometer Baseline, Week 7
Secondary Change in agonist muscle activation as measured by electromyography amplitude A measure of the capacity at which the muscle is activitated by the nervous system Baseline, Week 7
Secondary Change from baseline in isokinetic muscle activation at 6 weeks Electromyography root mean square during isokinetic contraction divided by root mean square during isometric contraction Baseline, Week 7
Secondary Change in antagonist co-activation as measured by electromyography amplitude A measure of the capacity at which the antagonist muscle is activated by the nervous system Baseline, Week 7
Secondary Change in isometric bicep strength as measured by newton-meters of torque Isometric strength of a muscle Baseline, Week 7
Secondary Change in isokinetic bicep strength as measured by newton-meters of torque Dynamic strength of a muscle contracting at a constant velocity Baseline, Week 7
Secondary Change in rate of torque development as measured by newton-meters per second A measure of the capacity to increase muscle torque rapidly as determined by the slope of the torque-time curve Baseline, Week 7
Secondary Change in walking speed as measured by time taken to walk 6 meters Measure of lower-body physical function Baseline, Week 7
Secondary Change in chair rise performance as measured by number of chair rises performed in 30 seconds Measure of lower-body physical function Baseline, Week 7
Secondary Change in chair rise power by watts by a linear transducer attached to hip during chair rise test Product of load and velocity as determined on a linear transducer Baseline, Week 7
Secondary Change in muscle composition as measured by ultrasound-derived grey-scale analysis Echo-intensity value derived from grey-scale analysis is indicative of amount of non-contractile tissue in muscle Baseline, Week 7
Secondary Change in skeletal muscle size as measured by ultrasound-derived cross-sectional Size of a muscle Baseline, Week 7
Secondary Change in fat mass as measured by kilograms Amount of fat tissue a person possesses estimated by bioelectrical impedance analysis Baseline, Week 7
Secondary Change in fat-free mass as measured by kilograms Amount of non-fat tissue a person possesses estimated by bioelectrical impedance analysis Baseline, Week 7
Secondary Change in body fat percentage as measured by fat tissue relative to fat-free tissue Relative amount of body fat a person possesses estimated by bioelectrical impedance analysis Baseline, Week 7
Secondary Change in hemoglobin A1c level as measured by blood drop analysis Blood drop analysis, obtained from fingerstick, measure of amount of blood sugar bound to hemoglobin Baseline, Week 7
Secondary Change in resting heart rate as measured by beats/min using oscillatory cuff Measure of cardiovascular fitness Baseline, Week 7
Secondary Change in resting blood pressure in millimeters of mercury using oscillatory cuff Measure of cardiovascular fitness Baseline, Week 7
Secondary Change in general feeling about knee extension and bicep curl exercise From a -5 to +5 on the Affective Feeling Scale Each exercise session of the 6-week intervention
Secondary Change in grip width on elastic band as measured by distance of hand placements on band Indication of progression in training intensity Baseline, 3 weeks, 5 weeks
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