Mechanisms Underlying Local and Systemic Effects of Massage

NCT04131712 | Completed Results DMC

• 2 other identifiers: 43499R21AT010847
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether massage can attenuate the loss of muscle mass in humans after a short period of disuse.

Conditions

Muscle Atrophy

Keywords

Massage; Muscle; Extracellular Vesicles; Atrophy

Outcome Measures

Primary Outcomes (2)

• Percent Change in Myofiber Cross Sectional Area (CSA).

  The ability of massage to attenuate the atrophic response to disuse will be determined. Muscle biopsies of the vastus lateralis will be used to quantify myofiber cross-sectional area. The percent change in myofiber size between day 7 and day -2 was used. Calculation details: \[(day 7 CSA) - (day -2 CSA)/(day -2 CSA)\]\*100

  9 days

• Myofibrillar Protein Synthesis Rate (MyoKsyn).

  The ability of massage to attenuate the atrophic response to disuse due to protein synthesis will be determined. Muscle biopsies of the vastus lateralis will be used to quantify protein synthesis rates.

  9 days

Secondary Outcomes (2)

• Percent Change in Serum Extracellular Vesicle Number (EV #).

  9 days

• Percent Change in the Expression of Muscle Rab27b mRNA.

  9 days

Study Arms (4)

Ambulatory Control

NO INTERVENTION

Following baseline assessments, participants will be randomized into the ambulatory group for the remainder of the study. Atrophy will not be induced and massage intervention will not be applied. Ambulatory groups will be recruited following the immobilized groups.

Ambulatory Massage

SHAM COMPARATOR

Following baseline assessments, participants will be randomized into the ambulatory group for the remainder of the study. No atrophy induction. Four massage treatments will be applied every other day until the end of the study. Ambulatory groups will be recruited following the immobilized groups.

Other: Massage

Immobilization Control

NO INTERVENTION

Following baseline assessments, participants will be randomized into the unilateral lower limb suspension group undergoing atrophy for the remainder of the study. Massage intervention will not be applied.

Immobilization Massage

EXPERIMENTAL

Following baseline assessments, participants will be randomized into the unilateral lower limb suspension group undergoing atrophy for the remainder of the study. Four massage treatments will be applied every other day until the end of the study.

Other: Massage

Interventions

Massage OTHER

A custom-made cyclic compressive loading (CCL) device will be used to apply a mechanical load to the left thigh of the participants. Massage application using a 35 Newton load will be applied for 15 minutes every other day over the course of 7 days for a total of four massages.

Ambulatory Massage; Immobilization Massage

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18-30 years of age.
• All races and ethnic backgrounds.
• Non-smoker and generally healthy.

You may not qualify if:

• Have a current lower extremity musculoskeletal injury or compromised musculoskeletal function that would not allow the safe use of crutches or a brace.
• Previous lower extremity surgeries or injury.
• Activities of daily living require long periods of standing or driving a manual transmission car.
• Body mass index (BMI) under 27.
• Evidence or signs and symptoms of metabolic syndrome or disorder (diagnosis of diabetes or insulin resistance, elevated BP, high fasting blood sugar, abnormal cholesterol or triglyceride levels).
• Thyroid disorder.
• Acute or chronic infections.
• Use of systemic steroids, anabolic steroids, or growth hormone.
• Chronic aspirin or NSAID use (unless it can be safely stopped prior to the biopsies), and any other use of an anticoagulant (e.g., Coumadin) or history of bleeding including history of hypo- or hyper-coagulation disorders.
• Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
• Pregnancy.

Sponsors & Collaborators

• Esther Dupont-Versteegden: lead
• University of Oklahoma: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Atrophy

Interventions

Massage

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Douglas Long
• Organization: University of Kentucky

delong2@uky.edu

859-323-5438

Study Officials

• Esther Dupont-Versteegden, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome assessors are blinded to treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: August 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)