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Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00760383
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Hans Dreyer, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Dietary Supplement: Essential amino acids
Dietary Supplement: Alanine
Enrollment 60
Recruitment Details Participants were recruited from the Slocum Center for Orthopedics and Sports Medicine.
Pre-assignment Details Participants were selected from surgical candidates from the Slocum Center for Orthopedics and Sports Medicine. All subjects were scheduled to undergo primary TKA.
Arm/Group Title EAA+PT ALA+PT
Hide Arm/Group Description

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

Period Title: Overall Study
Started 21 19
Completed 16 12
Not Completed 5 7
Reason Not Completed
moved away; withdrew; medical reasons             5             7
Arm/Group Title EAA+PT ALA+PT Total
Hide Arm/Group Description

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
68  (5) 70  (5) 69  (5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  28.6%
2
  10.5%
8
  20.0%
>=65 years
15
  71.4%
17
  89.5%
32
  80.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
13
  61.9%
12
  63.2%
25
  62.5%
Male
8
  38.1%
7
  36.8%
15
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Stair Time up
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EAA+PT ALA+PT
Hide Arm/Group Description:

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: seconds
7  (1) 8  (1)
2.Primary Outcome
Title Quadriceps Muscle Strength
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EAA+PT ALA+PT
Hide Arm/Group Description:

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: Newtons
65  (8) 81  (7)
3.Secondary Outcome
Title Mid-thigh Muscle Volume
Hide Description Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EAA+PT ALA+PT
Hide Arm/Group Description:

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

Overall Number of Participants Analyzed 16 12
Mean (Standard Error)
Unit of Measure: Volume (cm^3)
109  (11) 108  (9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EAA+PT ALA+PT
Hide Arm/Group Description

20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.

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.

All-Cause Mortality
EAA+PT ALA+PT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
EAA+PT ALA+PT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EAA+PT ALA+PT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hans C. Dreyer, PT, PhD
Organization: Human Physiology, University of Oregon
Phone: 541-346-5775
EMail: hcdreyer@uoregon.edu
Other Publications:
Layout table for additonal information
Responsible Party: Hans Dreyer, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00760383    
Other Study ID Numbers: 1K01HD057332 ( U.S. NIH Grant/Contract )
1K01HD057332 ( U.S. NIH Grant/Contract )
First Submitted: September 25, 2008
First Posted: September 26, 2008
Results First Submitted: April 17, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014