Recruiting

Strength Training

Sponsor:

Texas Christian University

Code:

NCT05097092

Conditions

Muscle Disuse Atrophy

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Orthopedic immobilization

Unilateral resistance training

Bilateral resistance training

Study Details

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.

Conditions

Muscle Disuse Atrophy

Study ID

NCT05097092

Start date

Aug 13, 2021

Status verified date

Oct, 2021

Completion date

Aug 14, 2023

Anticipated

Primary completion date

Aug 13, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Orthopedic immobilization

Orthopedic immobilization will be performed with a sling and swathe.

Unilateral resistance training

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

Bilateral resistance training

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

Primary outcome measure

  • Changes in isometric muscle strength [ Time Frame: Changes from baseline at 5 and 10 weeks ]
  • Changes in dynamic muscle strength [ Time Frame: Changes from baseline at 5 and 10 weeks ]
  • Changes in muscle size [ Time Frame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks ]
  • Changes in lean mass [ Time Frame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks ]
  • Changes in EMG amplitude [ Time Frame: Changes from baseline at 5 and 10 weeks ]
  • Changes in action potential amplitude [ Time Frame: Changes from baseline at 5 and 10 weeks ]

Central Contacts and Locations

Locations

TCU RIC

Recruiting

Fort Worth, Texas, United States, 76126

Contacts

Joshua C Carr

917-257-6867joshua.carr@tcu.edu

More Information

Sponsor

Texas Christian University

Last update posted

Oct 27, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Christian University on 2021-10-27.