Trial Outcomes & Findings for Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation (NCT NCT00760383)
NCT ID: NCT00760383
Last Updated: 2014-12-04
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-12-04
Participant Flow
Participants were recruited from the Slocum Center for Orthopedics and Sports Medicine.
Participants were selected from surgical candidates from the Slocum Center for Orthopedics and Sports Medicine. All subjects were scheduled to undergo primary TKA.
Participant milestones
| Measure |
EAA+PT
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.
|
ALA+PT
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 Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
EAA+PT
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.
|
ALA+PT
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 Study
moved away; withdrew; medical reasons
|
5
|
7
|
Baseline Characteristics
Muscle Regrowth During Physical Rehabilitation and Amino Acid Supplementation
Baseline characteristics by cohort
| Measure |
EAA+PT
n=21 Participants
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.
|
ALA+PT
n=19 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 5 • n=5 Participants
|
70 years
STANDARD_DEVIATION 5 • n=7 Participants
|
69 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
EAA+PT
n=16 Participants
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.
|
ALA+PT
n=12 Participants
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.
|
|---|---|---|
|
Stair Time up
|
7 seconds
Standard Error 1
|
8 seconds
Standard Error 1
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
EAA+PT
n=16 Participants
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.
|
ALA+PT
n=12 Participants
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.
|
|---|---|---|
|
Quadriceps Muscle Strength
|
65 Newtons
Standard Error 8
|
81 Newtons
Standard Error 7
|
SECONDARY outcome
Timeframe: 6 weeksAnalysis 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.
Outcome measures
| Measure |
EAA+PT
n=16 Participants
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.
|
ALA+PT
n=12 Participants
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.
|
|---|---|---|
|
Mid-thigh Muscle Volume
|
109 Volume (cm^3)
Standard Error 11
|
108 Volume (cm^3)
Standard Error 9
|
Adverse Events
EAA+PT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ALA+PT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hans C. Dreyer, PT, PhD
Human Physiology, University of Oregon
Phone: 541-346-5775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place