CClinicalTrials.gg
Status unknownNCT05097092STARUpdated Oct 27, 2021

Strength Training Augmenting Rehabilitation

An interventional study of Orthopedic immobilization and Unilateral resistance training in Muscle Disuse Atrophy, sponsored by Texas Christian University. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by Texas Christian University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the detailed description

The present study will examine the time course of muscle strength and size adaptations in two groups of volunteers during immobilization and retraining. Both groups will undergo temporary muscle disuse by wearing a shoulder sling and swathe on their non-dominant arm for \~≥10 hours/day for four weeks. One group (immobilization + unilateral training) will perform progressive unilateral strength training of the free limb throughout the immobilization period. The other group (immobilization control) will not undergo any training during the immobilization period. Following immobilization, both groups will undergo four weeks of bilateral strength training to retrain the immobilized arm.

02

Conditions studied

  • Muscle Disuse Atrophy
03

In context

Muscular Disorders, Atrophic

51 studies on the registry are indexed under Muscular Disorders, Atrophic; 11 are open to participants now.

This study's planned enrollment of 20 is below the median of 24 across 48 interventional studies indexed under Muscular Disorders, Atrophic.

Browse Muscular Disorders, Atrophic studies →

Lead sponsor

Texas Christian University is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • a body mass index between 18 - 35 kg/m2
  • 18-35 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Immobilization control

    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 immobilization · Other: Bilateral resistance training

  • Experimental
    Immobilization with unilateral training

    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 immobilization · Other: Unilateral resistance training · Other: Bilateral resistance training

Interventions

  • ProcedureOrthopedic immobilization

    Orthopedic immobilization will be performed with a sling and swathe.

  • OtherUnilateral resistance training

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

  • OtherBilateral resistance training

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

06

What researchers measure

Primary outcomes

  1. Changes in isometric muscle strength

    MVC (Newton)

    Time frame: Changes from baseline at 5 and 10 weeks

  2. Changes in dynamic muscle strength

    1RM (lbs)

    Time frame: Changes from baseline at 5 and 10 weeks

  3. Changes in muscle size

    Ultrasound muscle thickness of biceps brachii and triceps brachii

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

  4. Changes in lean mass

    DEXA

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

  5. Changes in EMG amplitude

    Surface EMG

    Time frame: Changes from baseline at 5 and 10 weeks

  6. Changes in action potential amplitude

    Surface EMG Decomposition

    Time frame: Changes from baseline at 5 and 10 weeks

07

Study locations

2 of 2 sites recruiting
  • TCU Neuromuscular Physiology Laboratory
    Fort Worth, Texas 76126, United States
    Enrolling by invitation
  • TCU RIC
    Fort Worth, Texas 76126, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05097092
Lead sponsor
Texas Christian University
Responsible party
Joshua Carr (Assistant Professor, Texas Christian University) — Principal investigator
First posted
Oct 27, 2021
Start date
Aug 13, 2021
Primary completion
Aug 13, 2023 (estimated)
Completion
Aug 14, 2023 (estimated)
Last update
Oct 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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