Muscle Disuse AtrophySTARNCT05097092
Strength Training Augmenting Rehabilitation
A study testing Orthopedic immobilization, Unilateral resistance training and Bilateral resistance training in people with Muscle Disuse Atrophy, run by Texas Christian University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Disuse Atrophy
- What is being tested?
- Orthopedic immobilization, Unilateral resistance training and Bilateral resistance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2021to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Enrolling by invitation
TCU Neuromuscular Physiology Laboratory
Fort Worth, Texas, 76126
- Recruiting
TCU RIC
Fort Worth, Texas, 76126
Joshua C Carr, 917-257-6867, joshua.carr@tcu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Disuse Atrophy
- Being tested
- Orthopedic immobilization, Unilateral resistance training, Bilateral resistance training
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic immobilizationProcedure or surgery
Orthopedic immobilization will be performed with a sling and swathe.
Unilateral resistance trainingOther
Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.
Bilateral resistance trainingOther
Bilateral resistance training will be performed by both arms in both groups during Phase 2.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization control | Experimental | 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. Receives: Procedure: Orthopedic immobilization; Other: Bilateral resistance training |
| Immobilization with unilateral training | Experimental | 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. Receives: Procedure: Orthopedic immobilization; Other: Unilateral resistance training; Other: Bilateral resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in isometric muscle strength
MVC (Newton)
Measured: Changes from baseline at 5 and 10 weeks
Changes in dynamic muscle strength
1RM (lbs)
Measured: Changes from baseline at 5 and 10 weeks
Changes in muscle size
Ultrasound muscle thickness of biceps brachii and triceps brachii
Measured: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
Changes in lean mass
DEXA
Measured: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
Changes in EMG amplitude
Surface EMG
Measured: Changes from baseline at 5 and 10 weeks
Changes in action potential amplitude
Surface EMG Decomposition
Measured: Changes from baseline at 5 and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start13 Aug 2021
- Primary completion13 Aug 2023 (estimated)
- Study completion14 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Disuse AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Carr, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097092
- Sponsor's protocol ID
- 2021-101
- Acronym
- STAR
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Augmenting Rehabilitation - 1
- ClinicalTrials.gov ID
- NCT05097092
- Acronym / sponsor ID
- STAR / 2021-101
- Conditions
- Muscle Disuse Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 13 Aug 2023 (estimated)
- Study completion
- 14 Aug 2023 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization control | Experimental | Procedure: Orthopedic immobilization, Other: Bilateral resistance trainingThe 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. |
| Immobilization with unilateral training | Experimental | Procedure: Orthopedic immobilization, Other: Unilateral resistance training, Other: Bilateral resistance trainingThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopedic immobilizationOrthopedic immobilization will be performed with a sling and swathe. | Procedure or surgery | Immobilization control, Immobilization with unilateral training |
| Unilateral resistance trainingUnilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1. | Other | Immobilization with unilateral training |
| Bilateral resistance trainingBilateral resistance training will be performed by both arms in both groups during Phase 2. | Other | Immobilization control, Immobilization with unilateral training |
Primary outcome
Changes in isometric muscle strength
Time frame: Changes from baseline at 5 and 10 weeks
MVC (Newton)
Changes in dynamic muscle strength
Time frame: Changes from baseline at 5 and 10 weeks
1RM (lbs)
Changes in muscle size
Time frame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
Ultrasound muscle thickness of biceps brachii and triceps brachii
Changes in lean mass
Time frame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
DEXA
Changes in EMG amplitude
Time frame: Changes from baseline at 5 and 10 weeks
Surface EMG
Changes in action potential amplitude
Time frame: Changes from baseline at 5 and 10 weeks
Surface EMG Decomposition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopedic immobilization, Unilateral resistance training and Bilateral resistance training in people with Muscle Disuse Atrophy, run by Texas Christian University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in isometric muscle strength (time frame: Changes from baseline at 5 and 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.