Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation
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Purpose
The general hypothesis is that in older adults muscle regrowth after an acute musculoskeletal stress will be positively influenced by traditional physical rehabilitation, and further enhanced by nutritional supplementation. Using state-of-the-art stable isotope methodologies for the study of muscle metabolism and methodologies for the measurement of cell signaling, we will test the following specific hypotheses: 1) Total knee arthroplasty (TKA) induces an acute net protein catabolism mainly by reducing muscle protein synthesis; 2) TKA induced catabolism is attenuated by the ingestion of essential amino acids (EAA); 3) EAA supplementation in combination with physical therapy (PT) will stimulate muscle protein synthesis and mTOR signaling to a greater extent than PT with Placebo; and 4) EAA supplementation during TKA PT rehabilitation will improve muscle strength, muscle volume and functional outcomes to a greater extent than PT with Placebo.
Public Benefit: This research will focus rehabilitation efforts on specific and currently unresolved mechanisms responsible for muscle loss following total knee replacement in older adults. While knee pain due to bone arthritis is often alleviated after knee replacement, complete return of physical function and independence is difficult to achieve. This research will help to restore physical function and independence in the rapidly growing population of older adults with knee arthritis.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Dietary Supplement: Essential amino acids Dietary Supplement: Alanine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation |
- Muscle Protein Synthesis and Breakdown [ Time Frame: Post-op Day #1 ] [ Designated as safety issue: No ]
- Physical function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Quadriceps muscle strength [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- muscle cross-sectional area [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EAA+PT
20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
|
Dietary Supplement: Essential amino acids
Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session.
Other Names:
|
|
Placebo Comparator: ALA+PT
20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
|
Dietary Supplement: Alanine
Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session.
Other Name: Alanine
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Total Knee Arthroplasty surgical candidate
Exclusion Criteria:
- Overt muscle disease
Contacts and Locations| Contact: Crystal Mills | 541-868-3232 | crystal.mills@slocumcenter.com |
| Contact: Hans C. Dreyer, PT, PhD | 541-346-5775 | hcdreyer@uoregon.edu |
| United States, Oregon | |
| University of Oregon | Recruiting |
| Eugene, Oregon, United States, 97401-1240 | |
| Contact: Hans C Dreyer, PT, PhD 541-346-5775 hcdreyer@uoregon.edu | |
| Contact: Crystal Mills, CCRP (541) 868-3232 crystal.mills@slocumcenter.com | |
| Slocum Center for Orthopedics and Sports Medicine | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Contact: Crystal Mills 541-868-3232 crystal.mills@slocumcenter.com | |
| Contact: Hans C. Dreyer, PT, PhD 541-346-5775 hcdreyer@uoregon.edu | |
| Principal Investigator: Brian A. Jewett, MD | |
| Principal Investigator: Brick A. Lantz, MD | |
| Principal Investigator: Steven N. Shah, MD | |
| Principal Investigator: | Hans C Dreyer, PT, PhD | Assistant Professor, Department of Human Physiology |
More Information
Additional Information:
Publications:
| Responsible Party: | Hans C. Dreyer, University of Oregon, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00760383 History of Changes |
| Other Study ID Numbers: | 1K01HD057332, 1K01HD057332 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Total Knee Arthroplasty Osteoarthritis Muscle Metabolism Rehabilitation Physical Therapy |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013