Overcoming TWEAK Signaling to Restore Muscle and Mobility After Joint Replacement (TWEAK)
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ClinicalTrials.gov Identifier: NCT02628795 |
Recruitment Status :
Completed
First Posted : December 11, 2015
Last Update Posted : July 7, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Behavioral: PRT + FM Other: Usual Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Overcoming TWEAK Signaling to Restore Muscle and Mobility After Joint Replacement |
Actual Study Start Date : | October 2015 |
Actual Primary Completion Date : | September 1, 2020 |
Actual Study Completion Date : | February 28, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: PRT + FM
Progressive resistance training + functional mobility training 3 d/wk x 16 wk
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Behavioral: PRT + FM
Supervised progressive resistance training + functional mobility training (PRT+FM) 3 days per week for 16 weeks post-surgery. Other: Usual Care Post-surgical usual care activities including any prescribed physical therapy |
Active Comparator: Usual Care
Post-surgical usual care including physical therapy
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Other: Usual Care
Post-surgical usual care activities including any prescribed physical therapy |
- Change in unilateral (surgical) thigh muscle mass (unit of measure = grams) [ Time Frame: Pre-surgery to 16 weeks post-surgery ]Primary muscle mass outcome of Aim 1
- Change in unilateral (surgical) knee extension power (unit of measure = watts) [ Time Frame: Pre-surgery to 16 weeks post-surgery ]Primary functional outcome of Aim 1
- Change in short physical performance battery (SPPB) (unit of measure = score) [ Time Frame: From 16 weeks post-surgery to 26 and 52 weeks post-surgery ]Primary outcome of Aim 3
- Muscle inflammation susceptibility (MuIS) status (unit of measure = relative value) [ Time Frame: At the time of surgery ]Primary outcome of Aim 2: Muscle inflammation susceptibility (MuIS) defined by TWEAK receptor gene expression
- Change in muscle fiber size (unit of measure = micrometers squared) [ Time Frame: From the time of surgery to 16 weeks post-surgery ]
- Change in unilateral (surgical) knee extension isometric strength (unit of measure = Newton-meters) [ Time Frame: Pre-surgery to 16 weeks post-surgery ]
- Change in maximum 10-meter gait speed (unit of measure = meters per second) [ Time Frame: Pre-surgery to 16 weeks post-surgery ]
- Change in free-living physical activity (unit of measure = steps per day) [ Time Frame: Pre-surgery to 8, 16, 26, and 52 weeks post-surgery ]Via wearable technology (i.e. step counter)
- Change in self-reported health status (unit of measure = score) [ Time Frame: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery ]Via Short Form-36v2 Health Survey (SF-36v2)
- Change in cellular and molecular markers (unit of measure = arbitrary units) [ Time Frame: From the time of surgery to 16 weeks post-surgery ]Experiments using muscle tissue and primary muscle satellite cells collected from surgical and contralateral limbs.
- Change in fatigue (unit of measure = score) [ Time Frame: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery ]Via Patient Reported Outcomes Measurement Information System (PROMIS)
- Change in pain (unit of measure = score) [ Time Frame: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery ]Via Patient Reported Outcomes Measurement Information System (PROMIS)
- Change in depression (unit of measure = score) [ Time Frame: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery ]Beck Depression Inventory (BDI II)
- Change in fatigue severity (unit of measure = score) [ Time Frame: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery ]Fatigue Severity Scale (FSS)

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Between the ages 40 and 80 y.
- Scheduled to undergo elective total hip or knee replacement specifically for the surgical indication of end-stage osteoarthritis.
- First-time hip or knee replacement.
- Capable of providing informed consent (cognitively intact if consenting to surgery).
Exclusion Criteria:
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Any surgical indication other than first-time total joint replacement specifically for end-stage osteoarthritis.
- Bilateral knee/ hip replacement
- History of alcoholism or liver disease.
- Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin.
- Any individual with end-stage disease and/or a life expectancy less than one year.
- Pregnancy.
- Lactating Women.
- Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
- Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia, congestive heart failure.
- Uncontrolled diabetes mellitus.
- Any other condition or events considered exclusionary by the PIs and/or physician Co-Is.
- Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
- Phenylketonuria (phenylalanine tracer for metabolic studies).
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., growth hormone (GH), insulin-like growth factor-I (IGF-I)) therapy.
- Body mass index ≥ 35.
- History of lower body progressive resistance training within the past year.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628795
United States, Alabama | |
UAB Center for Exercise Medicine | |
Birmingham, Alabama, United States, 35205 |
Principal Investigator: | Marcas M Bamman, PhD | University of Alabama at Birmingham | |
Principal Investigator: | S Louis Bridges, MD, PhD | University of Alabama at Birmingham |
Responsible Party: | Marcas M. Bamman, PhD, Professor and Director, UAB Center for Exercise Medicine, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT02628795 |
Other Study ID Numbers: |
R01HD084124 ( U.S. NIH Grant/Contract ) R01HD084124 ( U.S. NIH Grant/Contract ) |
First Posted: | December 11, 2015 Key Record Dates |
Last Update Posted: | July 7, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data might be provided on written request in aggregate form. |
total hip arthroplasty total knee arthroplasty |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |