Clinical trial

The Effect of Percussive Massage on the Maintenance of Skeletal Muscle and Vascular Health During Limb Immobilization

Name
IRB2022-118
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-12-31
Trial end
2024-07-31
Status
Recruiting
Treatment
percussive massage
30 minutes of percussive massage will be administered twice per day during the 10 day immobilization period using a percussive massage device
Arms:
Massage
Leg Immobilization
All subjects will have their left leg immobilized using an immobilization brace for 10 days
Arms:
Control, Massage
Size
36
Primary endpoint
knee extensor muscle strength
Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Vastus lateralis cross-sectional area
Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Skeletal muscle mitochondrial function
Immediately before the onset of leg immobilization and after 10 days of leg immobilization
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel design', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2023-09-26

1 organization

1 product

2 indications

Indication
Massage Therapy