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| Name | Class |
|---|---|
| Betsi Cadwaladr University Health Board | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic kidney disease progressive resistance training group | Experimental | 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 | Sham Comparator | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
|
| Healthy controls progressive resistance training group | Experimental | 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 | Sham Comparator | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive resistance training programme | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Cross Sectional Area | Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle. | Change from baseline in cross sectional area at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength | Bilateral knee extensor isometric strength. | Change from baseline in muscle strength at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie H MacDonald, PhD | Bangor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust | Bangor | Gwynedd | LL57 2PW | United Kingdom |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Chronic Kidney Disease Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
| FG002 | 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. |
| FG003 | Healthy Controls Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol. All participants completing the study were analyzed. | Posted | Mean | Standard Deviation | cm2 | Change from baseline in cross sectional area at 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Small sample size in healthy control group. Variable gender mix in all groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Kirkman | UWalesBangor | 00 44 1248 388254 | pepa03@bangor.ac.uk |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Sham exercise | Other | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
|
| Progressive resistance training | Other | 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. |
|
| Sham exercise | Other | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
|
| Physician Decision |
|
| Started home haemodialysis |
|
| Chronic Kidney Disease Sham Exercise Group |
Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
| BG002 | 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. |
| BG003 | Healthy Controls Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
| OG002 | 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. |
| OG003 | Healthy Controls Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband |
|
|
|
| Secondary | Muscle Strength | Bilateral knee extensor isometric strength. | Not Posted | Change from baseline in muscle strength at 12 weeks |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Chronic Kidney Disease Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband | 0 | 11 | 0 | 11 |
| EG002 | 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. | 0 | 5 | 0 | 5 |
| EG003 | Healthy Controls Sham Exercise Group | Lower body stretching exercise using the easiest rehabilitation elastic Theraband | 0 | 4 | 0 | 4 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |