Strength Training Augmenting Rehabilitation

Muscle Disuse Atrophy Clinical Trial

— STAR  

Official title:

Strength Training Augmenting Rehabilitation - 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097092
• Other study ID #: 2021-101
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: October 2021
• Source: Texas Christian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 14, 2023
• Est. primary completion date: August 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscle Disuse Atrophy
• Muscular Disorders, Atrophic

Intervention

Procedure:
• Orthopedic immobilization
Orthopedic immobilization will be performed with a sling and swathe.

Other:
• 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.

Locations

Country	Name	City	State
United States	TCU Neuromuscular Physiology Laboratory	Fort Worth	Texas
United States	TCU RIC	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in isometric muscle strength	MVC (Newton)	Changes from baseline at 5 and 10 weeks
Primary	Changes in dynamic muscle strength	1RM (lbs)	Changes from baseline at 5 and 10 weeks
Primary	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
Primary	Changes in lean mass	DEXA	Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
Primary	Changes in EMG amplitude	Surface EMG	Changes from baseline at 5 and 10 weeks
Primary	Changes in action potential amplitude	Surface EMG Decomposition	Changes from baseline at 5 and 10 weeks