- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06853275
The Influence of Movement Velocity Biofeedback on Muscle Activation and Self Perception in Older Adults With Sarcopenia
The overall objective for this clinical trial is to provide evidence for internal and external cueing for physical therapists and other rehabilitation clinicians to optimize resistance training within rehabilitation for older adults. The main questions it aims to answer are:
- What is the impact of external focus (providing velocity of movement for each repetition) compared to internal focus (i.e., no cues, control group) on physical percent velocity loss and neuromuscular activation in older adults with sarcopenia?
- Does internal and external focus influence motivation and perceptual workload following resistance training in older adults with sarcopenia?
Researchers will compare external focus to internal focus to see if external focus impacts percent velocity loss, motivation, and perceived workload.
Participants will:
- Visit the lab once per week for 3 weeks
- Perform exercise testing using a leg press
- Answer questionnaires regarding perceived workload and motivation before and after exercise
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rashelle Hoffman, PT, DPT, PhD
- Phone Number: 402-280-5691
- Email: rashellehoffman@creighton.edu
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68178
- Recruiting
- Creighton University
-
Contact:
- Shannon Walsh
- Phone Number: 402-280-2322
- Email: shannonwalsh@creighton.edu
-
Principal Investigator:
- Rashelle Hoffman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Community-dwelling older adults 60-95 years of age
- Physically independent
- Free of severe mental impairment
- Score 4 or greater on the SARC-F sarcopenia questionnaire
Exclusion Criteria:
- Participated in a structured resistance training program in the last 12 months
- Had a lower extremity injury or surgical intervention within the past 6 months
- Have neuromuscular (i.e., Parkinson's Disease, Multiple Sclerosis), circulatory, or edema pathology
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External Focus
|
Participants will perform a short, standardized warm-up (1 set of 10 repetitions of 20% of the participant's estimated 1-repetition maximum).
Following the warm-up, participants will perform 30 repetitions using 50% of their estimated 1-repetition maximum on a leg press machine.
Participants will receive visual feedback from a linear position transducer for each repetition, indicating the speed of the last repetition/movement.
|
|
Other: Internal Focus
|
Arm Description: Participants will perform a short, standardized warm-up (1 set of 10 repetitions of 20% of the participant's estimated 1RM).
Following the warm-up, participants will perform 30 repetitions using 50% of their estimated 1-repetition maximum on a leg press machine.
Participants will NOT receive visual feedback for each repetition.
This is the control condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Velocity Loss
Time Frame: Week 1 and Week 2 Timepoints
|
The linear position transducer is a spring-powered retractable apparatus that attaches to the leg press on one end and to the machine near the participant's hip joint.
Velocity data from a linear position transducer will be collected following each repetition.
Percent velocity loss (%VL) measures the reduction in the movement speed from the initial repetition to the final repetition.
The %VL will quantify the level of fatigue and performance decline that occurs throughout the repetitions of leg press.
This would suggest that a higher %VL would indicate a greater degree of fatigue, while a lower %VL loss would indicate a better ability to maintain movement velocity across the repetitions.
|
Week 1 and Week 2 Timepoints
|
|
Muscle Activation
Time Frame: Baseline, Week 1, and Week 2 Timepoints
|
To examine muscle activation, surface electromyographic (sEMG) signals will be collected in millivolts (mV) during each repetition using wireless sEMG sensors from the right vastus lateralis.
A higher number of millivolts is associated with greater muscular activation.
All sEMG signals will use a commercially available signal acquisition system.
To optimize signal quality, the skin will be prepared, and the surface electrodes will be secured to the skin with skin-sensor adhesive in a standardized position directly above the muscle in line with the muscle fiber pennation in a bipolar fashion.
An electrogoniometer will be placed across the right knee's joint space.
The electrogoniometer will be calibrated to 90° flexion and 180° full extension of the knee joint.
|
Baseline, Week 1, and Week 2 Timepoints
|
|
Motivation
Time Frame: Week 1 and Week 2 Timepoints
|
The Dundee Stress State Questionnaire (DDSQ) has been used to determine task stress and performance impact of stress on task completion.
Our proposal focuses on the motivation construct (15 item questionnaire, ~5 minutes to complete) of the DDSQ which has been shown to be reliable and scored on a 4-point Likert scale (Extremely = 4 Very much = 3 Somewhat = 2 A little bit = 1 Not at all = 0).
The maximum score possible is 60 points and minimum score possible is 0 points.
Higher scores indicate higher motivation.
Note that certain items are reverse coded when scoring.
Motivation will be assessed before sessions to determine baseline motivation to complete the resistance training protocol and 10 minutes after the resistance training protocol to determine if the visual movement velocity biofeedback improves motivation throughout the resistance training protocol.
|
Week 1 and Week 2 Timepoints
|
|
Perceived Workload
Time Frame: Week 1 and Week 2 Timepoints
|
Perceived workload will be assessed using the NASA task index (NASA-TLX).
This questionnaire assesses six separate indices that examine the mental demand, physical demand, temporal demand, performance, effort, and frustration level following the completion of the resistance training protocol.
Adjusted scores range from 0-500 with higher scores indicate greater demand, failure, higher effort, or higher frustration.
The NASA-TLX will provide valuable information about how visual movement velocity biofeedback may change the perceived workload compared to the non-biofeedback condition.
|
Week 1 and Week 2 Timepoints
|
Collaborators and Investigators
Sponsor
Collaborators
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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