NCT05097092

Brief Summary

This project aims to determine whether a novel strength training rehabilitation protocol can diminish the negative consequences of limb immobilization and expedite the restoration of muscle function during retraining in healthy individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

August 13, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

September 22, 2021

Last Update Submit

October 14, 2021

Conditions

Muscle Disuse Atrophy

Outcome Measures

Primary Outcomes (6)

  • Changes in isometric muscle strength

    MVC (Newton)

    Changes from baseline at 5 and 10 weeks

  • Changes in dynamic muscle strength

    1RM (lbs)

    Changes from baseline at 5 and 10 weeks

  • Changes in muscle size

    Ultrasound muscle thickness of biceps brachii and triceps brachii

    Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks

  • Changes in lean mass

    DEXA

    Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks

  • Changes in EMG amplitude

    Surface EMG

    Changes from baseline at 5 and 10 weeks

  • Changes in action potential amplitude

    Surface EMG Decomposition

    Changes from baseline at 5 and 10 weeks

Study Arms (2)

Immobilization control

EXPERIMENTAL

The immobilization control group will undergo arm immobilization. Immobilization will be implemented with four weeks of muscle unloading with a sling and swathe on the nondominant arm. The sling will suspend the arm at the elbow joint with the elbow in a flexed position at 90°, the swathe will then wrap around the participant to fix the arm against the body.

Procedure: Orthopedic immobilizationOther: Bilateral resistance training

Immobilization with unilateral training

EXPERIMENTAL

The immobilization with unilateral training group will undergo arm immobilization for four with a sling and swathe on the nondominant arm. The sling will suspend the arm at the elbow joint with the elbow in a flexed position at 90°, the swathe will then wrap around the participant to fix the arm against the body. The free (non-immobilzed) arm of this group will undergo heavy strength training twice per week throughout the immobilization period. The training will consist of unilateral dumbbell shoulder press and biceps curl.

Procedure: Orthopedic immobilizationOther: Unilateral resistance trainingOther: Bilateral resistance training

Interventions

Orthopedic immobilizationPROCEDURE

Orthopedic immobilization will be performed with a sling and swathe.

Immobilization controlImmobilization with unilateral training
Unilateral resistance trainingOTHER

Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.

Immobilization with unilateral training
Bilateral resistance trainingOTHER

Bilateral resistance training will be performed by both arms in both groups during Phase 2.

Immobilization controlImmobilization with unilateral training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a body mass index between 18 - 35 kg/m2
  • years of age
  • right-hand dominant
  • willingness to comply with the immobilization requirements
  • willingness to refrain from strength training outside of the study
  • willingness to comply with the strength training procedures of the study

You may not qualify if:

  • a personal or family history of blood clots
  • a personal or family history of thyroid disorders
  • previous orthopedic surgeries to the upper limbs and/or joint pain of the upper limbs in the last 6 months
  • neuromuscular or metabolic disorders
  • osteoarthritis
  • use of hormone replacement therapy (ie., testosterone, estrogen, and/or growth hormone pharmaceuticals)
  • pregnancy and/or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TCU Neuromuscular Physiology Laboratory

Fort Worth, Texas, 76126, United States

ENROLLING BY INVITATION

TCU RIC

Fort Worth, Texas, 76126, United States

RECRUITING

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 27, 2021

Study Start

August 13, 2021

Primary Completion

August 13, 2023

Study Completion

August 14, 2023

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations

US(2)