SarcopeniaNCT06853275
The Influence of Movement Velocity Biofeedback on Muscle Activation and Self Perception in Older Adults With Sarcopenia
A study testing Experimental: External Focus and Other: Internal Focus in people with Sarcopenia and Sarcopenia in Elderly, run by Creighton University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Sarcopenia, Sarcopenia in Elderly, Age-associated Muscle Loss
- What is being tested?
- Experimental: External Focus and Other: Internal Focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Shannon Walsh, 402-280-2322, shannonwalsh@creighton.edu
Rashelle Hoffman
About this study
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?
Read more
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
- Being tested
- Experimental: External Focus, Other: Internal Focus
- Keywords
- Geriatrics, Neuromuscular, Rehabilitation, Sarcopenia, Velocity-based training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: External FocusBehavioural
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 FocusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| External Focus | Experimental | Not described Receives: Behavioral: Experimental: External Focus |
| Internal Focus | Other | Not described Receives: Behavioral: Other: Internal Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Velocity Loss
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.
Measured: Week 1 and Week 2 Timepoints
Muscle Activation
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.
Measured: Baseline, Week 1, and Week 2 Timepoints
Motivation
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.
Measured: Week 1 and Week 2 Timepoints
Perceived Workload
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.
Measured: Week 1 and Week 2 Timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853275
- Sponsor's protocol ID
- 2005068
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data will be housed in the Creighton Digital Repository. Sharing beyond this registry will be handled on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Movement Velocity Biofeedback on Muscle Activation and Self Perception in Older Adults With Sarcopenia
- ClinicalTrials.gov ID
- NCT06853275
- Acronym / sponsor ID
- 2005068
- Keywords
- Geriatrics, Neuromuscular, Rehabilitation, Sarcopenia, Velocity-based training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2025 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Focus | Experimental | Behavioral: Experimental: External Focus |
| Internal Focus | Other | Behavioral: Other: Internal Focus |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Experimental: External FocusParticipants 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. | Behavioural | External Focus |
| Other: Internal FocusArm 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. | Behavioural | Internal Focus |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes. The study data will be housed in the Creighton Digital Repository. Sharing beyond this registry will be handled on a case-by-case basis.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: External Focus and Other: Internal Focus in people with Sarcopenia and Sarcopenia in Elderly, run by Creighton University at 1 site 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rashelle Hoffman, PT, DPT, PhD (402-280-5691, rashellehoffman@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Velocity Loss (time frame: Week 1 and Week 2 Timepoints). The study lists 4 primary outcomes in all. 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 18 Mar 2026.