End Stage Renal Failure on Dialysis Clinical Trial
Official title:
A Structured Exercise and Educational Intervention to Increase Physical Activity in Haemodialysis Patients: a Feasibility Study
There is a well established link between physical inactivity and increased mortality in the general population and across many of the more common disease areas including chronic kidney disease (CKD). Patients with CKD have very high levels of morbidity and mortality and are known to have low fitness levels. Randomised controlled trials of exercise have demonstrated the benefits of physical activity for CKD patients. Despite this, physical activity levels remain low and translating these research findings into clinical practice is challenging. This feasibility study aims to assess the feasibility and acceptability of an instructor led structured exercise programme which includes an educational component to engage and increase physical activity levels in haemodialysis patients attending the Oxford University Hospitals Trust haemodialysis unit. Consented participants will fill in a self reported physical activity questionnaire (Human Activity Profile), partake in functional mobility assessments including (Timed-Up and Go) and a chair based exercise programme. At the end of the study, participants, and nursing staff will undertake a semi-structured interview aimed at understanding acceptability of the intervention. The results of this feasibility study will then be used to inform whether a larger trial in haemodialysis patients is feasible. All questionnaires, physical activity interventions and interviews will be undertaken during routine visits to the haemodialysis unit.
There is a well established link between physical inactivity and increased mortality in the general population and patients with chronic kidney disease (CKD) have low fitness levels when compared to their healthy counterparts (50% of expected norm when commencing dialysis therapy). Trials have shown that physical activity confers many physical and mental health benefits in this patient population, with improvements in fitness, walking capacity, health of the heart and quality of life; indeed, national guidelines now consider physical activity to be a cornerstone of disease management (Cochrane Collaboration 2006; Workgroup KD 2005). CKD patients have lower levels of physical activity than age-matched controls; this is particularly marked for older patients and those on dialysis. The Department of Health recommends ≥150 mins/ week of moderate intensity PA (accumulated in bouts of at least 10 minutes) for the general population (DoH UK Physical Activity Guidelines 2011). Many studies have sought to characterise the most effective forms of exercise for CKD patients. Recent attention has focussed on intradialytic cycling, with studies showing benefits not only for fitness and endurance but also muscle strength, power, and physical function. However, translating research guided physical activity programmes into routine clinical practice is challenging, requiring consideration of patients' physical and psychological barriers to exercise. Assessing the impact of any activity programme requires comparison of health and exercise behaviours pre and post intervention. Several self-report physical activity questionnaires are available but the Human Activity Profile has been validated in CKD patients (Johansen et al. 2001). However, information obtained from patient self-reporting is subjective and prone to bias. Objective measurement devices such as accelerometers are more accurate. Feasibility of an effective intervention to increase physical activity requires understanding of perceptions of exercise in the population of interest. In this way, the intervention can be specifically targeted to take account of perceived benefits and barriers towards physical activity and thereby increase compliance. This study will provide: 1)feasibility and acceptability of an instructor led chair based exercise programme and educational package (booklet); 2) both self-report and objective measurements of physical activity levels in a sample of haemodialysis patients. This key information will later be used to assess whether a informed large scale PA intervention study in haemodialysis patients is feasible. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01561118 -
DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis
|
N/A | |
Withdrawn |
NCT03645720 -
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
|
N/A | |
Active, not recruiting |
NCT02598635 -
Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
|
Phase 4 | |
Terminated |
NCT01643733 -
Study on Fistuloplasty Using Flow Measurement Guidance
|
N/A | |
Not yet recruiting |
NCT03169400 -
Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
|
N/A | |
Completed |
NCT02439697 -
A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients
|
N/A | |
Completed |
NCT02063490 -
Nurse-led Intervention to Improve Phosphate Binder Adherence
|
N/A | |
Completed |
NCT04106310 -
Theranova vs High-flux HD Comparison
|
N/A | |
Recruiting |
NCT06056102 -
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
|
Phase 1 | |
Completed |
NCT04698512 -
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
|
||
Completed |
NCT02819011 -
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
|
Phase 2 | |
Completed |
NCT02484118 -
Hemodialysis Blood Flow and Urea Clearance
|
N/A | |
Enrolling by invitation |
NCT01641757 -
Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy,
|
Phase 2 | |
Completed |
NCT03172039 -
Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit
|
N/A | |
Completed |
NCT03897231 -
Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis
|
||
Withdrawn |
NCT03145662 -
High Pressure Balloon vs Cutting Balloon
|
N/A | |
Completed |
NCT02621918 -
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
|
N/A | |
Completed |
NCT01356615 -
Low Molecular Weight Heparin for Hemodialysis Anticoagulation
|
N/A | |
Terminated |
NCT01033357 -
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
|
N/A | |
Recruiting |
NCT05927532 -
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
|
N/A |