Clinical trial NCT06099678: Enhancing Strength Gains With the Power of the Mind
Official title: The Effect of Combining Maximal Mental Effort With Elastic Band Training on Strength and Neuromuscular Adaptations in Older Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Kennesaw State University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 45
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups will perform different types of elastic band training, and a control group will not perform any elastic band training.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bicep curl strength as measured by load lifted in pounds
timeFrame: Baseline, Week 7
Secondary outcomes:
measure: Change in voluntary activation as measured by ratio of superimposed torque to resting twitch torque
timeFrame: Baseline, Week 7
measure: Change in handgrip strength as measured in kilograms of force
timeFrame: Baseline, Week 7
measure: Change in agonist muscle activation as measured by electromyography amplitude
timeFrame: Baseline, Week 7
measure: Change from baseline in isokinetic muscle activation at 6 weeks
timeFrame: Baseline, Week 7
measure: Change in antagonist co-activation as measured by electromyography amplitude
timeFrame: Baseline, Week 7
measure: Change in isometric bicep strength as measured by newton-meters of torque
timeFrame: Baseline, Week 7
measure: Change in isokinetic bicep strength as measured by newton-meters of torque
timeFrame: Baseline, Week 7
measure: Change in rate of torque development as measured by newton-meters per second
timeFrame: Baseline, Week 7
measure: Change in walking speed as measured by time taken to walk 6 meters
timeFrame: Baseline, Week 7
measure: Change in chair rise performance as measured by number of chair rises performed in 30 seconds
timeFrame: Baseline, Week 7
measure: Change in chair rise power by watts by a linear transducer attached to hip during chair rise test
timeFrame: Baseline, Week 7
measure: Change in muscle composition as measured by ultrasound-derived grey-scale analysis
timeFrame: Baseline, Week 7
measure: Change in skeletal muscle size as measured by ultrasound-derived cross-sectional
timeFrame: Baseline, Week 7
measure: Change in fat mass as measured by kilograms
timeFrame: Baseline, Week 7
measure: Change in fat-free mass as measured by kilograms
timeFrame: Baseline, Week 7
measure: Change in body fat percentage as measured by fat tissue relative to fat-free tissue
timeFrame: Baseline, Week 7
measure: Change in hemoglobin A1c level as measured by blood drop analysis
timeFrame: Baseline, Week 7
measure: Change in resting heart rate as measured by beats/min using oscillatory cuff
timeFrame: Baseline, Week 7
measure: Change in resting blood pressure in millimeters of mercury using oscillatory cuff
timeFrame: Baseline, Week 7
measure: Change in general feeling about knee extension and bicep curl exercise
timeFrame: Each exercise session of the 6-week intervention
measure: Change in grip width on elastic band as measured by distance of hand placements on band
timeFrame: Baseline, 3 weeks, 5 weeks
Other outcomes:
measure: Change in exercising heart rate
timeFrame: Each exercise session of the 6-week intervention
measure: Change in calorie consumption as measured by kilocalories determined by dietary recall
timeFrame: Baseline, Week 7
measure: Change in protein consumption as measured by kilocalories determined by dietary recall
timeFrame: Baseline, Week 7
measure: Change in physical activity as measured by daily step count via Garmin Venu SQ smartwatch
timeFrame: Baseline, Week 7
Locations:
city: Kennesaw
country: United States
facility: Kennesaw State University
state: Georgia
city: Kennesaw
country: United States
facility: Kennesaw State University
state: Georgia
Study officials:
affiliation: Kennesaw State University
name: Garrett Hester, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: