Chronic Kidney Disease
Conditions
Keywords
Progressive Resistance Training/Exercise, Muscle wasting, Chronic Kidney Disease
Brief summary
The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis. It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.
Detailed description
Muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life. In other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. It is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. However, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients. Therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.
Interventions
OTHERProgressive resistance training programme
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.
OTHERSham exercise
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
OTHERProgressive resistance training
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.
Sponsors
Betsi Cadwaladr University Health Board
Bangor University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic kidney diseases stage five requiring maintenance hemodialysis.
Exclusion criteria
* Patients who have been receiving dialysis for less than 3 months; * Are under the age of 18years; * Have medical contradictions to participate in the exercise programs; * Any uncontrolled medical condition which does not allow participation in exercise; * Have known neuro-muscular disorders; * Have any other uncontrolled medical condition, including pregnancy; * Are not independently ambulant for 50 m; * Have received anabolic intervention, or had catabolic conditions within the last 3 months; * Have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance; * Are vulnerable to heat stress; * Or are unable to give consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Cross Sectional Area | Change from baseline in cross sectional area at 12 weeks | Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | Change from baseline in muscle strength at 12 weeks | Bilateral knee extensor isometric strength. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Chronic Kidney Disease Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband | 11 |
| 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. | 5 |
| Healthy Controls Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband | 4 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Started home haemodialysis | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Chronic Kidney Disease Sham Exercise Group | Healthy Controls Progressive Resistance Training Group | Chronic Kidney Disease Progressive Resistance Training Group | Healthy Controls Sham Exercise Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 4 Participants | 0 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 8 Participants | 4 Participants | 22 Participants |
| Age Continuous | 67 years STANDARD_DEVIATION 16 | 51 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 18 | 40 years STANDARD_DEVIATION 17 | 51 years STANDARD_DEVIATION 17 |
| Region of Enrollment United Kingdom | 11 participants | 5 participants | 12 participants | 4 participants | 32 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 7 Participants | 0 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 11 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Muscle Cross Sectional Area
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Time frame: Change from baseline in cross sectional area at 12 weeks
Population: Per protocol. All participants completing the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Kidney Disease Progressive Resistance Training Group | Muscle Cross Sectional Area | 3.24 cm2 | Standard Deviation 5.1 |
| Chronic Kidney Disease Sham Exercise Group | Muscle Cross Sectional Area | -4.62 cm2 | Standard Deviation 6.33 |
| Healthy Controls Progressive Resistance Training Group | Muscle Cross Sectional Area | 4.39 cm2 | Standard Deviation 3.43 |
| Healthy Controls Sham Exercise Group | Muscle Cross Sectional Area | -0.15 cm2 | Standard Deviation 2.1 |
Comparison: Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controlsp-value: 0.3ANCOVA
Comparison: Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.p-value: 0.0017ANOVA
Comparison: Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.p-value: 0.024ANOVA
Secondary
Muscle Strength
Bilateral knee extensor isometric strength.
Time frame: Change from baseline in muscle strength at 12 weeks