Clinical trial NCT04103177: Physical Activity in Haemodialysis Patients: a Feasibility Study
Official title: A Structured Exercise and Educational Intervention to Increase Physical Activity in Haemodialysis Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2019-09-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study will incorporate instructor led guidance of a range of chair-based exercises that focus on balance, strength, fitness, endurance and flexibility with some exercises having a cardiovascular component. These chair based exercises are drawn from programmes recommended for similar long term clinical conditions (e.g cardiovascular disease, sarcopenia, frail and elderly and renal disease) and can be performed in the clinical environment or at home.The intervention is multifaceted comprising of the following; an education booklet about PA and the chair based exercise programme, face to face instructor led support detailing the chair based exercises and instructor/nurse led motivational interviewing.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • Participant is willing and able to give informed consent for participation in the trial.

  * Male or Female, aged 18 years or above.
  * Undergoing regular haemodialysis (2 or 3 times per week) in the Oxford Main and Tarver Dialysis Units
  * Is able and willing to comply with all trial requirements.
  * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

* Unable to give consent
* Poor dialysis compliance
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
* Participant with life expectancy of less than 1 month and/or receiving palliative care.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Planning to leave Oxford Dialysis units within the study trial
* Absolute contra-indications to PA including:

  * Recent significant change in resting ECG suggesting significant ischaemia, recent Myocardial Infarction within 2 days or acute cardiac event
  * Unstable angina
  * Uncontrolled cardiac arrhythmia causing symptoms or haemodynamic compromise
  * Symptomatic severe aortic stenosis
  * Uncontrolled symptomatic heart failure
  * Acute pulmonary embolus or infarction
  * Acute myocarditis or pericarditis
  * Third degree heart block
  * Suspected or know dissecting aortic aneurysm
  * Acute systemic infection, accompanied by fever, body aches or swollen lymph glands

Primary outcomes:
measure: Semi structured interviews and questionnaires targeted to determine participant acceptability of PA intervention and the people delivering it
timeFrame: Interviews should last no longer than an hour and will be conducted at month 3 post baseline
Secondary outcomes:
measure: Change is being assessed 3 metre Timed Up and Go
timeFrame: Change from baseline functional mobility at 6 months
measure: Change is being assessed 10 metre walk test
timeFrame: Change from baseline functional mobility at 6 months
measure: Change is being assessed Hand grip strength
timeFrame: Change from baseline arm strength at 6 months
measure: Change is being assessed Wrist worn accelerometery data
timeFrame: Change from baseline of activity at 6 months
measure: Change is being assessed EQ-5D-3L questionnaire
timeFrame: Change from baseline quality of life at 6 months
measure: Change is being assessed IPOS Renal questionnaire
timeFrame: Change from baseline quality of life at 6 months
measure: Change is being assessed Human Activity profile questionnaire
timeFrame: Change from baseline of physical activity at 6 months
measure: Falls and Fractures questionnaire
timeFrame: Change from baseline
measure: Client Service Receipt Inventory Questionnaire
timeFrame: Change from baseline
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS FT
state: Oxfordshire
Study officials:
affiliation: University of Exeter
name: Helen Dawes, PhD
role: PRINCIPAL_INVESTIGATOR
References: