Trial record 1 of 9 for:    rehabilitation | Open Studies | NICHD [Lead]
Previous Study | Return to List | Next Study

Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hans C. Dreyer, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00760383
First received: September 25, 2008
Last updated: January 2, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Muscle Protein Synthesis and Breakdown [ Time Frame: Post-op Day #1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Histidine
  • Isoleucine
  • Leucine
  • Lysine
  • Methionine
  • Phenylalanine
  • Threonine
  • Valine
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
Criteria

Inclusion Criteria:

  • Total Knee Arthroplasty surgical candidate

Exclusion Criteria:

  • Overt muscle disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760383

Contacts
Contact: Crystal Mills 541-868-3232 crystal.mills@slocumcenter.com
Contact: Hans C. Dreyer, PT, PhD 541-346-5775 hcdreyer@uoregon.edu

Locations
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         
Sponsors and Collaborators
Investigators
Principal Investigator: Hans C Dreyer, PT, PhD Assistant Professor, Department of Human Physiology
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014