Massage TherapyNCT06053229
Effect of Percussive Massage on Skeletal Muscle During Limb Immobilization
A study testing percussive massage and Leg Immobilization in people with Massage Therapy and Muscular Atrophy, run by Brigham Young University at 1 site in United States.
Trial summary
The primary aims of this study are to determine the effect of percussive massage (30 min/session, 2 sessions/day, daily) during 10 days of unilateral limb immobilization on preserving muscle, vascular, and mitochondrial function. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Massage Therapy, Muscular Atrophy
- What is being tested?
- percussive massage and Leg Immobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Jul 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years old (women are pre-menopausal). We will exclude individuals over the age of 50 because the adaptive capability of skeletal muscle fundamentally changes with older age, and the risk from disuse increases. The findings of this study will help determine the risk benefit relationship of conducting a similar study in older individuals.
- Stable levels of physical activity for at least 6 months
- No history of lower extremity injury that would preclude their ability to perform knee extension exercise
Who cannot join
- Cigarette or marijuana smoker
- Pregnant or planning to become pregnant within next month
- Cardiovascular, metabolic disease or cognitive disease (e.g. Alzheimer's or mild cognitive impairment)
- Taking prescribed medications (e.g. blood pressure medication) or anti-depressants
- Habitual use of any type of massage or vibration on their thigh
- Note that subjects who are mentally unable to understand the consenting process and provide informed consent will not be included in this study.
Trial locations and contacts
1 site in 1 country.
Ty Hopkins, PhD contact
United States1 site, 1 recruiting
- Recruiting
Brigham Young University
Provo, Utah, 84602
Robert D Hyldahl, PhD, 801-422-1237, robhyldahl@byu.edu
Ty Hopkins, PhD, 8014221573, jthops@me.com
About this study
Official title: The Effect of Percussive Massage on the Maintenance of Skeletal Muscle and Vascular Health During Limb Immobilization
The primary aims of this study are to determine the effect of percussive massage (30 min/session, 2 sessions/day, daily) during 10 days of unilateral limb immobilization on preserving muscle, vascular, and mitochondrial function. The following hypotheses will be tested:
Hypothesis 1: Percussive massage will attenuate the loss of size, strength and endurance over the immobilization period compared to the control group, as measured by MRI, maximal isometric and isokinetic force production and muscle endurance test using Biodex dynamometry.
Read more
Hypothesis 2: Percussive massage will attenuate the loss of vascular function and blood flow compared to the control group as measured by passive leg movement and femoral artery blood flow.
Hypothesis 3: Percussive massage will attenuate the loss of skeletal muscle mitochondrial function and decrease H2O2 production during immobilization compared to the control group, as measured by high-resolution respirometry.
Read the detailed description
Phase 1. Pre-measures: Pre-measures will occur over the course of 2 days.
Visit 1:
MRI scan: Participants will report to the MRI facility and fill out an MRI safety screening form. Upon completion, a 3-Tesla magnet will be used to image their left thigh (for more detail on MRI protocol see section 7.4 below).
Visit 2:
Blood flow and vascular function measurement: Upon arrival, participants will rest on a chair for 15 minutes with their left leg resting on a rolling desktop to stabilize their heart rate and blood flow. Blood flow will be measured with Doppler Ultrasound at the Common Femoral Artery while the subjects rest and while their leg is passively moved through a 90° range of motion. This test will be repeated 3 times to determine the dilatory function of the resistance arteries of the leg.
Muscle biopsy: After completing the vascular function measurement, subjects will lie down on a treatment table. Their left thigh will be prepped, cleaned, numbed with lidocaine, and biopsied.
Muscle strength and endurance measurement: Subjects will be seated in a chair with their leg bent to 90° (hanging straight down) and ankle fastened in a custom brace that is attached to a strain gauge. Subjects will be asked to kick against the immovable brace multiple times at moderate intensities. They will then be asked to kick as hard as they can to determine their maximum voluntary contraction (MVC). Then they will kick at 40-45% of their MVC until the generated force drops below 40% of MVC.
Providing a knee brace and crutches: In this study, the subjects' left leg will undergo immobilization using an aluminum frame knee brace. Trained lab personnel will instruct the subjects on how to properly apply and remove the knee brace. Crutches will be provided so that they can get around while staying off the assigned leg. The subjects will be instructed on how to properly use the crutches. We will confirm their ability to use the crutches properly and practice going up and downstairs in order to increase their familiarity with the demands of using crutches. They will also need to fill out an activity assessment questionnaire during each lab visit and at home during the next 7 days of recovery after the biopsy.
Phase 2. Immobilization
The subjects are asked to apply the knee brace and start using crutches from the morning of the day they come for their 3rd visit. The immobilization period will last 10 days. The brace should be worn at all times throughout the day, but can be taken off at night during sleep. During each visit to the lab, the subjects will fill out the food log and activity assessment questionnaire.
Visit 3: Subjects will lie down on a treatment table, with their knee brace removed for 15 minutes to stabilize their heart rate and blood flow. Then their baseline blood flow will be measured with a doppler ultrasound at the common femoral artery. The subjects in the massage group will receive percussive massage on their thigh for 30 minutes and the subjects in the control group will lie down on the bed without receiving any treatment (the subjects are randomized into massage or control groups after they enroll in the study). Every 5 minutes, the percussive massage stops, and blood flow will be measured. There will be a total of 7 blood flow measurements (each for 30 seconds) during this visit.
Visit 4-20: The subjects will report to the lab twice a day to receive percussive massage (massage group) or lie on the bed (control group) for 30 minutes. In order to monitor the level of pressure the subjects received during the percussive massage, a pressure perception chart will be used. Based on the subject's feedback throughout the training session, the investigators will be able to keep the pressure at a moderate level
Visit 21: same as visit 3
Phase 3. Post-measures: Post-measures will occur in 1 day.
Visit 22: 24 hours after their 21st visit, the subjects will return the knee brace and crutches. Then they will undergo an MRI scan, vascular function measurement, biopsy, and muscle strength and endurance tests. All tests will be the same as pre-measures.
- Conditions
- Massage Therapy, Muscular Atrophy
- Being tested
- percussive massage, Leg Immobilization
- Keywords
- Massage, immobilization
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percussive massageDevice
30 minutes of percussive massage will be administered twice per day during the 10 day immobilization period using a percussive massage device
Leg ImmobilizationCombination product
All subjects will have their left leg immobilized using an immobilization brace for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Subjects will receive a daily 30 minute percussive massage treatment on the knee extensor muscles twice per day during the 10 day immobilization period Receives: Device: percussive massage; Combination Product: Leg Immobilization |
| Control | Sham comparator | This group will lie on the bed for a total of 30 minutes, but receive no massage Receives: Combination Product: Leg Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee extensor muscle strength
Assessed by dynamometry
Measured: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Vastus lateralis cross-sectional area
Assessed by MRI
Measured: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Skeletal muscle mitochondrial function
Assessed in muscle biopsies using in vivo respirometry
Measured: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage TherapyStudies 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
- Parallel groups
- Model description
- Randomized, parallel design
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rob Hyldahl, Brigham Young University
- Investigators
- Robert D Hyldahl, PhD, Principal investigator, Brigham Young University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053229
- Sponsor's protocol ID
- IRB2022-118
- Status last verified
- Aug 2024
- First submitted
- 15 Sep 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percussive Massage on the Maintenance of Skeletal Muscle and Vascular Health During Limb Immobilization
- ClinicalTrials.gov ID
- NCT06053229
- Acronym / sponsor ID
- IRB2022-118
- Conditions
- Massage Therapy, Muscular Atrophy
- Keywords
- Massage, immobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Sep 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 primary aims of this study are to determine the effect of percussive massage (30 min/session, 2 sessions/day, daily) during 10 days of unilateral limb immobilization on preserving muscle, vascular, and mitochondrial function. The following hypotheses will be tested:
Hypothesis 1: Percussive massage will attenuate the loss of size, strength and endurance over the immobilization period compared to the control group, as measured by MRI, maximal isometric and isokinetic force production and muscle endurance test using Biodex dynamometry.
Hypothesis 2: Percussive massage will attenuate the loss of vascular function and blood flow compared to the control group as measured by passive leg movement and femoral artery blood flow.
Hypothesis 3: Percussive massage will attenuate the loss of skeletal muscle mitochondrial function and decrease H2O2 production during immobilization compared to the control group, as measured by high-resolution respirometry.
Detailed description
Phase 1. Pre-measures: Pre-measures will occur over the course of 2 days.
Visit 1:
MRI scan: Participants will report to the MRI facility and fill out an MRI safety screening form. Upon completion, a 3-Tesla magnet will be used to image their left thigh (for more detail on MRI protocol see section 7.4 below).
Visit 2:
Blood flow and vascular function measurement: Upon arrival, participants will rest on a chair for 15 minutes with their left leg resting on a rolling desktop to stabilize their heart rate and blood flow. Blood flow will be measured with Doppler Ultrasound at the Common Femoral Artery while the subjects rest and while their leg is passively moved through a 90° range of motion. This test will be repeated 3 times to determine the dilatory function of the resistance arteries of the leg.
Muscle biopsy: After completing the vascular function measurement, subjects will lie down on a treatment table. Their left thigh will be prepped, cleaned, numbed with lidocaine, and biopsied.
Muscle strength and endurance measurement: Subjects will be seated in a chair with their leg bent to 90° (hanging straight down) and ankle fastened in a custom brace that is attached to a strain gauge. Subjects will be asked to kick against the immovable brace multiple times at moderate intensities. They will then be asked to kick as hard as they can to determine their maximum voluntary contraction (MVC). Then they will kick at 40-45% of their MVC until the generated force drops below 40% of MVC.
Providing a knee brace and crutches: In this study, the subjects' left leg will undergo immobilization using an aluminum frame knee brace. Trained lab personnel will instruct the subjects on how to properly apply and remove the knee brace. Crutches will be provided so that they can get around while staying off the assigned leg. The subjects will be instructed on how to properly use the crutches. We will confirm their ability to use the crutches properly and practice going up and downstairs in order to increase their familiarity with the demands of using crutches. They will also need to fill out an activity assessment questionnaire during each lab visit and at home during the next 7 days of recovery after the biopsy.
Phase 2. Immobilization
The subjects are asked to apply the knee brace and start using crutches from the morning of the day they come for their 3rd visit. The immobilization period will last 10 days. The brace should be worn at all times throughout the day, but can be taken off at night during sleep. During each visit to the lab, the subjects will fill out the food log and activity assessment questionnaire.
Visit 3: Subjects will lie down on a treatment table, with their knee brace removed for 15 minutes to stabilize their heart rate and blood flow. Then their baseline blood flow will be measured with a doppler ultrasound at the common femoral artery. The subjects in the massage group will receive percussive massage on their thigh for 30 minutes and the subjects in the control group will lie down on the bed without receiving any treatment (the subjects are randomized into massage or control groups after they enroll in the study). Every 5 minutes, the percussive massage stops, and blood flow will be measured. There will be a total of 7 blood flow measurements (each for 30 seconds) during this visit.
Visit 4-20: The subjects will report to the lab twice a day to receive percussive massage (massage group) or lie on the bed (control group) for 30 minutes. In order to monitor the level of pressure the subjects received during the percussive massage, a pressure perception chart will be used. Based on the subject's feedback throughout the training session, the investigators will be able to keep the pressure at a moderate level
Visit 21: same as visit 3
Phase 3. Post-measures: Post-measures will occur in 1 day.
Visit 22: 24 hours after their 21st visit, the subjects will return the knee brace and crutches. Then they will undergo an MRI scan, vascular function measurement, biopsy, and muscle strength and endurance tests. All tests will be the same as pre-measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel design
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Device: percussive massage, Combination Product: Leg ImmobilizationSubjects will receive a daily 30 minute percussive massage treatment on the knee extensor muscles twice per day during the 10 day immobilization period |
| Control | Sham comparator | Combination Product: Leg ImmobilizationThis group will lie on the bed for a total of 30 minutes, but receive no massage |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years old (women are pre-menopausal). We will exclude individuals over the age of 50 because the adaptive capability of skeletal muscle fundamentally changes with older age, and the risk from disuse increases. The findings of this study will help determine the risk benefit relationship of conducting a similar study in older individuals.
- Stable levels of physical activity for at least 6 months
- No history of lower extremity injury that would preclude their ability to perform knee extension exercise
Key exclusion criteria (6 listed)
- Cigarette or marijuana smoker
- Pregnant or planning to become pregnant within next month
- Cardiovascular, metabolic disease or cognitive disease (e.g. Alzheimer's or mild cognitive impairment)
- Taking prescribed medications (e.g. blood pressure medication) or anti-depressants
- Habitual use of any type of massage or vibration on their thigh
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 |
|---|---|---|
| percussive massage30 minutes of percussive massage will be administered twice per day during the 10 day immobilization period using a percussive massage device | Device | Massage |
| Leg ImmobilizationAll subjects will have their left leg immobilized using an immobilization brace for 10 days | Combination product | Control, Massage |
Primary outcome
knee extensor muscle strength
Time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Assessed by dynamometry
Vastus lateralis cross-sectional area
Time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Assessed by MRI
Skeletal muscle mitochondrial function
Time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Assessed in muscle biopsies using in vivo respirometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
Ty Hopkins, PhD contact
Robert D Hyldahl, PhD principal investigator
Brigham Young University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percussive massage and Leg Immobilization in people with Massage Therapy and Muscular Atrophy, run by Brigham Young 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 3 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 13 Aug 2024. 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. Some participants in this study may receive a placebo. 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 Robert D Hyldahl, PhD (8014221237, robhyldahl@byu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee extensor muscle strength (time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization). The study lists 3 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 13 Aug 2024.