Back to resultsStrength Training Augmenting Rehabilitation (STAR)
Primary Purpose
Muscle Disuse Atrophy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthopedic immobilization
Unilateral resistance training
Bilateral resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Disuse Atrophy
Eligibility Criteria
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
Sites / Locations
- TCU Neuromuscular Physiology Laboratory
- TCU RICRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immobilization control
Immobilization with unilateral training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in isometric muscle strength
MVC (Newton)
Changes in dynamic muscle strength
1RM (lbs)
Changes in muscle size
Ultrasound muscle thickness of biceps brachii and triceps brachii
Changes in lean mass
DEXA
Changes in EMG amplitude
Surface EMG
Changes in action potential amplitude
Surface EMG Decomposition
Secondary Outcome Measures
Full Information
NCT ID
NCT05097092
First Posted
September 22, 2021
Last Updated
October 14, 2021
Sponsor
Texas Christian University
1. Study Identification
Unique Protocol Identification Number
NCT05097092
Brief Title
Strength Training Augmenting Rehabilitation
Acronym
STAR
Official Title
Strength Training Augmenting Rehabilitation - 1
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
August 13, 2023 (Anticipated)
Study Completion Date
August 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Disuse Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immobilization control
Arm Type
Experimental
Arm Description
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.
Arm Title
Immobilization with unilateral training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Orthopedic immobilization
Intervention Description
Orthopedic immobilization will be performed with a sling and swathe.
Intervention Type
Other
Intervention Name(s)
Unilateral resistance training
Intervention Description
Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.
Intervention Type
Other
Intervention Name(s)
Bilateral resistance training
Intervention Description
Bilateral resistance training will be performed by both arms in both groups during Phase 2.
Primary Outcome Measure Information:
Title
Changes in isometric muscle strength
Description
MVC (Newton)
Time Frame
Changes from baseline at 5 and 10 weeks
Title
Changes in dynamic muscle strength
Description
1RM (lbs)
Time Frame
Changes from baseline at 5 and 10 weeks
Title
Changes in muscle size
Description
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
Title
Changes in lean mass
Description
DEXA
Time Frame
Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
Title
Changes in EMG amplitude
Description
Surface EMG
Time Frame
Changes from baseline at 5 and 10 weeks
Title
Changes in action potential amplitude
Description
Surface EMG Decomposition
Time Frame
Changes from baseline at 5 and 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
TCU Neuromuscular Physiology Laboratory
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76126
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
TCU RIC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua C Carr
Phone
917-257-6867
Email
joshua.carr@tcu.edu
12. IPD Sharing Statement
Learn more about this trial
Strength Training Augmenting Rehabilitation
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