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This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured exercise program | Active Comparator | Participants will be randomised at 3 months into either this group or the comparator of usual exercise. |
|
| Vitamin D | Experimental | Cholecalciferol 2000U per day will be given to all participants for the duration of the study |
|
| Usual exercise | Placebo Comparator | Participants randomised to this arm, at 3 months, will continue on their usual exercise routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Exercise program | Other | 30 minutes on an exercise bicycle during every dialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity - modified shuttle walk test | Basesline, 3 & 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life with KDQOL | Baseline, 3 & 6 months | |
| Quadriceps Strength | Baseline, 3 & 6 months | |
| Serum phosphate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Bull | Sir Charles Gairdner Hospital | Principal Investigator |
| Neil Boudville | Sir Charles Gairdner Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| C104450 | 25-hydroxyvitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cholecalciferol (25-Hydroxyvitamin D) | Drug | Cholecalciferol 2000U per day will be given for duration of study to all participants |
|
| Usual exercise | Other | Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months |
|
| baselibe, 3 & 6 months |
| Feeling thermometer | Baseline, 3 & 6 months |
| Timed up and go | baseline, 3 & 6 months |
| Falls | continuous |
| Pulse wave velocity | baseline, 3 & 6 months |
| Bioimpedance | Baseline, 3 & 6 months |
| D052776 |
| Female Urogenital Diseases |
| 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 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |