NCT06053229

Brief 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. 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 Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

September 15, 2023

Last Update Submit

August 12, 2024

Conditions

Massage TherapyMuscular Atrophy

Keywords

Massageimmobilization

Outcome Measures

Primary Outcomes (3)

  • knee extensor muscle strength

    Assessed by dynamometry

    Immediately before the onset of leg immobilization and after 10 days of leg immobilization

  • Vastus lateralis cross-sectional area

    Assessed by MRI

    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

    Immediately before the onset of leg immobilization and after 10 days of leg immobilization

Study Arms (2)

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

Device: percussive massageCombination Product: Leg Immobilization

Control

SHAM COMPARATOR

This group will lie on the bed for a total of 30 minutes, but receive no massage

Combination Product: Leg Immobilization

Interventions

percussive massageDEVICE

30 minutes of percussive massage will be administered twice per day during the 10 day immobilization period using a percussive massage device

Massage
Leg ImmobilizationCOMBINATION_PRODUCT

All subjects will have their left leg immobilized using an immobilization brace for 10 days

ControlMassage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham Young University

Provo, Utah, 84602, United States

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Robert D Hyldahl, PhD

    Brigham Young University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert D Hyldahl, PhD

CONTACT

8014221237robhyldahl@byu.edu

Ty Hopkins, PhD

CONTACT

8014221573

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 25, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)