HealthyNCT06099678
Enhancing Strength Gains With the Power of the Mind
A study testing Elastic Band Training and Elastic Band Training with Maximal Mental Effort in people with Healthy, run by Kennesaw State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Elastic Band Training and Elastic Band Training with Maximal Mental Effort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Kennesaw State University
Kennesaw, Georgia, 30144
Garrett Hester, Ph.D.
- Recruiting
Kennesaw State University
Kennesaw, Georgia, 30144
Garrett M Hester, Ph.D., 470-578-4267, ghester4@kennesaw.edu
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Elastic Band Training, Elastic Band Training with Maximal Mental Effort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Band TrainingBehavioural
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 EffortBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Elastic Band Training | Experimental | This group will perform moderate intensity, whole-body elastic band training. Receives: Behavioral: Elastic Band Training |
| Elastic Band Training with Maximal Mental Effort | Experimental | This group will perform moderate intensity, whole-body elastic band training with maximal mental effort during muscle contraction. Receives: Behavioral: Elastic Band Training with Maximal Mental Effort |
| Control | No intervention | This group will not perform any training and maintain their regular level of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 7
Secondary outcomes (21)
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
Measured: Baseline, Week 7
Change in handgrip strength as measured in kilograms of force
Upper-body strength as measured by a handgrip dynamometer
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
Change in isometric bicep strength as measured by newton-meters of torque
Isometric strength of a muscle
Measured: Baseline, Week 7
Change in isokinetic bicep strength as measured by newton-meters of torque
Dynamic strength of a muscle contracting at a constant velocity
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
Change in walking speed as measured by time taken to walk 6 meters
Measure of lower-body physical function
Measured: Baseline, Week 7
Change in chair rise performance as measured by number of chair rises performed in 30 seconds
Measure of lower-body physical function
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
Change in skeletal muscle size as measured by ultrasound-derived cross-sectional
Size of a muscle
Measured: Baseline, Week 7
Change in fat mass as measured by kilograms
Amount of fat tissue a person possesses estimated by bioelectrical impedance analysis
Measured: Baseline, Week 7
Change in fat-free mass as measured by kilograms
Amount of non-fat tissue a person possesses estimated by bioelectrical impedance analysis
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
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
Measured: Baseline, Week 7
Change in resting heart rate as measured by beats/min using oscillatory cuff
Measure of cardiovascular fitness
Measured: Baseline, Week 7
Change in resting blood pressure in millimeters of mercury using oscillatory cuff
Measure of cardiovascular fitness
Measured: Baseline, Week 7
Change in general feeling about knee extension and bicep curl exercise
From a -5 to +5 on the Affective Feeling Scale
Measured: Each exercise session of the 6-week intervention
Change in grip width on elastic band as measured by distance of hand placements on band
Indication of progression in training intensity
Measured: Baseline, 3 weeks, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two intervention groups will perform different types of elastic band training, and a control group will not perform any elastic band training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kennesaw State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garrett Hester, Kennesaw State University
- Investigators
- Garrett Hester, Ph.D., Principal investigator, Kennesaw State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099678
- Sponsor's protocol ID
- 2024-Harper
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Maximal Mental Effort With Elastic Band Training on Strength and Neuromuscular Adaptations in Older Females
- ClinicalTrials.gov ID
- NCT06099678
- Acronym / sponsor ID
- 2024-Harper
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kennesaw State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Two intervention groups will perform different types of elastic band training, and a control group will not perform any elastic band training.
| Arm | Type | Receives |
|---|---|---|
| Elastic Band Training | Experimental | Behavioral: Elastic Band TrainingThis group will perform moderate intensity, whole-body elastic band training. |
| Elastic Band Training with Maximal Mental Effort | Experimental | Behavioral: Elastic Band Training with Maximal Mental EffortThis group will perform moderate intensity, whole-body elastic band training with maximal mental effort during muscle contraction. |
| Control | No intervention | –This group will not perform any training and maintain their regular level of physical activity. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic Band TrainingThis training intervention will be 6 weeks of moderate-intensity elastic band training, including whole-body and isolated muscle exercises. | Behavioural | Elastic Band Training |
| Elastic Band Training with Maximal Mental EffortThis 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. | Behavioural | Elastic Band Training with Maximal Mental Effort |
Primary outcome
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
21 secondary outcomes
Change in voluntary activation as measured by ratio of superimposed torque to resting twitch torque
Time frame: Baseline, Week 7
Change in handgrip strength as measured in kilograms of force
Time frame: Baseline, Week 7
Change in agonist muscle activation as measured by electromyography amplitude
Time frame: Baseline, Week 7
Change from baseline in isokinetic muscle activation at 6 weeks
Time frame: Baseline, Week 7
Change in antagonist co-activation as measured by electromyography amplitude
Time frame: Baseline, Week 7
Change in isometric bicep strength as measured by newton-meters of torque
Time frame: Baseline, Week 7
Change in isokinetic bicep strength as measured by newton-meters of torque
Time frame: Baseline, Week 7
Change in rate of torque development as measured by newton-meters per second
Time frame: Baseline, Week 7
Change in walking speed as measured by time taken to walk 6 meters
Time frame: Baseline, Week 7
Change in chair rise performance as measured by number of chair rises performed in 30 seconds
Time frame: 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
Change in muscle composition as measured by ultrasound-derived grey-scale analysis
Time frame: Baseline, Week 7
Change in skeletal muscle size as measured by ultrasound-derived cross-sectional
Time frame: Baseline, Week 7
Change in fat mass as measured by kilograms
Time frame: Baseline, Week 7
Change in fat-free mass as measured by kilograms
Time frame: Baseline, Week 7
Change in body fat percentage as measured by fat tissue relative to fat-free tissue
Time frame: Baseline, Week 7
Change in hemoglobin A1c level as measured by blood drop analysis
Time frame: Baseline, Week 7
Change in resting heart rate as measured by beats/min using oscillatory cuff
Time frame: Baseline, Week 7
Change in resting blood pressure in millimeters of mercury using oscillatory cuff
Time frame: Baseline, Week 7
Change in general feeling about knee extension and bicep curl exercise
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garrett Hester, Ph.D. principal investigator
Kennesaw State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band Training and Elastic Band Training with Maximal Mental Effort in people with Healthy, run by Kennesaw State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garrett Hester, Ph.D. (470-578-4267, ghester4@kennesaw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bicep curl strength as measured by load lifted in pounds (time frame: Baseline, Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.