Strength Training Augmenting Rehabilitation (STAR)

Strength Training Augmenting Rehabilitation - 1

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Disuse Atrophy
• Intervention / Treatment: Procedure: Orthopedic immobilization; Other: Bilateral resistance training; Other: Unilateral resistance training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76126
      • Enrolling by invitation
      • TCU Neuromuscular Physiology Laboratory
    • Fort Worth, Texas, United States, 76126
      • Recruiting
      • TCU RIC
      • Contact: Joshua C Carr; Phone Number: 917-257-6867; Email: joshua.carr@tcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Orthopedic immobilization will be performed with a sling and swathe.; Other: Bilateral resistance training; Bilateral resistance training will be performed by both arms in both groups during Phase 2.
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; Orthopedic immobilization will be performed with a sling and swathe.; Other: Bilateral resistance training; Bilateral resistance training will be performed by both arms in both groups during Phase 2.; Other: Unilateral resistance training; Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Texas Christian University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2021
• Primary Completion (ANTICIPATED): August 13, 2023
• Study Completion (ANTICIPATED): August 14, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic
• Other Study ID Numbers: 2021-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No