The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Exercise capacity - modified shuttle walk test
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stable on dialysis for at least 3 months
- •Able to obtain informed consent
- •Medically stable
- •Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%)
- •Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline
Exclusion Criteria
- •Limb Amputation
- •Impaired cognition
- •Impaired vision
- •Haemoglobin concentration < 110g/L
- •Change in Erythropoiesis stimulating agent dose over the last 2 months
- •Unable or unwilling to comply with exercise program
Arms & Interventions
Structured exercise program
Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
Intervention: Structured Exercise program (Other)
Vitamin D
Cholecalciferol 2000U per day will be given to all participants for the duration of the study
Intervention: Cholecalciferol (25-Hydroxyvitamin D) (Drug)
Usual exercise
Participants randomised to this arm, at 3 months, will continue on their usual exercise routine
Intervention: Usual exercise (Other)
Outcomes
Primary Outcomes
Exercise capacity - modified shuttle walk test
Time Frame: Basesline, 3 & 6 months
Secondary Outcomes
- Quality of life with KDQOL(Baseline, 3 & 6 months)
- Quadriceps Strength(Baseline, 3 & 6 months)
- Serum phosphate(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)
Investigators
Neil Boudville
Associate Professor
Sir Charles Gairdner Hospital