An interventional study of percussive massage and Leg Immobilization in Massage Therapy and Muscular Atrophy, sponsored by Brigham Young University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Brigham Young University · Not applicable, Interventional, and Basic science
Among 115 studies in Muscular Atrophy with a site in United States — 15 open to participants now, 26 under way, 2 of them phase 3. Muscular Atrophy · United States.
Among the 115 studies in Muscular Atrophy with a site in United States, this one is the 56th largest by planned enrollment of the 105 interventional ones that give a count, is one of 10 that started in 2023, is one of 57 with no phase, reaches primary completion later than 2 of the 25 other live ones, and was the 98th registered.
412 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.
Browse Muscular Atrophy studies →15 of the 115 studies in Muscular Atrophy with a site in United States are open now. Recruiting first, the newest first:
Sam Houston State University · Sites in United States
Brigham Young University · Sites in United States
University of Utah · Sites in United States
Michael C Willey · Sites in United States
Tufts Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 51 Muscular Atrophy studies recruiting now, 24 (47%) set no upper age limit and 13 (25%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
115 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 27 · Phase 3 13 · Phase 4 4
First in 1995; this study’s year is marked. 10 started in 2023.
This study's planned enrollment of 36 is close to the median of 40 across 326 interventional studies indexed under Muscular Atrophy.
Median enrollment 40 across the 105 interventional studies, 61 across the 9 observational. Of the 81 that completed or were terminated, 41 (51%) have results posted.
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27 of 115 have an industry lead sponsor. The 10 most frequent:
Brigham Young University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Brigham Young University has 2 studies filed under Muscular Atrophy — fewer than ten, so there is no comparison to draw.
13 of the studies in Muscular Atrophy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06050668Michael C WilleyEssential Amino Acid Supplementation for Femoral Fragility Fractures | 2026-12 |
| NCT04809714University of Alabama at BirminghamThe Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture | 2026-12-13 |
| NCT07843095Sam Houston State UniversityProtein Supplementation During Luteal Phase to Stop Protein Degradation | 2026-12-17 |
| NCT06136221University of PennsylvaniaTesting LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease | 2026-12-30 |
| NCT03332238Hospital for Special Surgery, New YorkStromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears | 2026-12-31 |
Among the 115 studies in Muscular Atrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a daily 30 minute percussive massage treatment on the knee extensor muscles twice per day during the 10 day immobilization period
Device: percussive massage · Combination Product: Leg Immobilization
This group will lie on the bed for a total of 30 minutes, but receive no massage
Combination Product: Leg Immobilization
30 minutes of percussive massage will be administered twice per day during the 10 day immobilization period using a percussive massage device
All subjects will have their left leg immobilized using an immobilization brace for 10 days
knee extensor muscle strength
Assessed by dynamometry
Time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Vastus lateralis cross-sectional area
Assessed by MRI
Time frame: 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
Time frame: Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.
Of 168 non-industry interventional studies with no phase under Muscular Atrophy, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 21 months is close to that.
Counting every sponsor, half of 174 studies reached it within 22 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Brigham Young University