Trial Outcomes & Findings for Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients (NCT NCT01007838)
NCT ID: NCT01007838
Last Updated: 2012-01-05
Results Overview
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Change from baseline in cross sectional area at 12 weeks
Results posted on
2012-01-05
Participant Flow
Chronic kidney patients were recruited from local renal units. Healthy controls were recruited from the North Wales Community. Recruitment period was from January 2009 to July 2011.
Participant milestones
| Measure |
Chronic Kidney Disease Progressive Resistance Training Group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Chronic Kidney Disease Sham Exercise Group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
Healthy Controls Progressive Resistance Training Group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Healthy Controls Sham Exercise Group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
5
|
4
|
|
Overall Study
COMPLETED
|
9
|
11
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease Progressive Resistance Training Group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Chronic Kidney Disease Sham Exercise Group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
Healthy Controls Progressive Resistance Training Group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Healthy Controls Sham Exercise Group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Started home haemodialysis
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease Progressive Resistance Training Group
n=12 Participants
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Chronic Kidney Disease Sham Exercise Group
n=11 Participants
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
Healthy Controls Progressive Resistance Training Group
n=5 Participants
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Healthy Controls Sham Exercise Group
n=4 Participants
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age Continuous
|
48 years
STANDARD_DEVIATION 18 • n=5 Participants
|
67 years
STANDARD_DEVIATION 16 • n=7 Participants
|
51 years
STANDARD_DEVIATION 13 • n=5 Participants
|
40 years
STANDARD_DEVIATION 17 • n=4 Participants
|
51 years
STANDARD_DEVIATION 17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in cross sectional area at 12 weeksPopulation: Per protocol. All participants completing the study were analyzed.
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Outcome measures
| Measure |
Chronic Kidney Disease Progressive Resistance Training Group
n=9 Participants
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Chronic Kidney Disease Sham Exercise Group
n=11 Participants
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
Healthy Controls Progressive Resistance Training Group
n=5 Participants
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
|
Healthy Controls Sham Exercise Group
n=4 Participants
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
|
|---|---|---|---|---|
|
Muscle Cross Sectional Area
|
3.24 cm2
Standard Deviation 5.10
|
-4.62 cm2
Standard Deviation 6.33
|
4.39 cm2
Standard Deviation 3.43
|
-0.15 cm2
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Change from baseline in muscle strength at 12 weeksBilateral knee extensor isometric strength.
Outcome measures
Outcome data not reported
Adverse Events
Chronic Kidney Disease Progressive Resistance Training Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Kidney Disease Sham Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls Progressive Resistance Training Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls Sham Exercise Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place