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Strength Training Augmenting Rehabilitation

NCT ID: NCT05097092

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2023-08-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Disuse Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Orthopedic immobilization

Intervention Type PROCEDURE

Orthopedic immobilization will be performed with a sling and swathe.

Bilateral resistance training

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Orthopedic immobilization

Intervention Type PROCEDURE

Orthopedic immobilization will be performed with a sling and swathe.

Unilateral resistance training

Intervention Type OTHER

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

Bilateral resistance training

Intervention Type OTHER

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

Interventions

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Orthopedic immobilization

Orthopedic immobilization will be performed with a sling and swathe.

Intervention Type PROCEDURE

Unilateral resistance training

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

Intervention Type OTHER

Bilateral resistance training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Christian University

OTHER

Sponsor Role lead

Responsible Party

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Joshua Carr

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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TCU Neuromuscular Physiology Laboratory

Fort Worth, Texas, United States

Site Status ENROLLING_BY_INVITATION

TCU RIC

Fort Worth, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Joshua C Carr

Role: primary

Other Identifiers

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2021-101

Identifier Type: -

Identifier Source: org_study_id