Physical Activity in Haemodialysis Patients: a Feasibility Study

NCT ID: NCT04103177

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-05-29

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.

Conditions

End Stage Renal Failure on Dialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

20 participants to receive physical activity educational booklet with instructions on chair based exercises, Instructor-led training on how to perform the chair based exercises, two times a week, over a 6 week period, and motivational interviewing and prompts.

Group Type: EXPERIMENTAL

Chair based exercises in the dialysis environment

Intervention Type: OTHER

Each participant will be given an educational / information booklet. It will include when the right time to engage in Physical Activity. The Chair-based Exercise Program will be the focus of the exercise intervention with written step- by-step instructions with demonstrative image of the exercises. Further details included in this booklet will include, information regarding the benefits of exercise including walking and safety measures in undertaking the exercises.

Sports Exercise Instructor led Chair-based Exercise Programme Patients will be given Sports Exercise Instructor led training on how to perform the chair-based exercises, for 6 weeks. This will be delivered during one of the patients' dialysis sessions. The Instructor will deliver a short 10 minute session to patients and deliver safety instruction.

Motivational interviewing Motivational interviewing will consist of discussion to encourage the participant without coercion and help them develop goals.

Interventions

Chair based exercises in the dialysis environment

Each participant will be given an educational / information booklet. It will include when the right time to engage in Physical Activity. The Chair-based Exercise Program will be the focus of the exercise intervention with written step- by-step instructions with demonstrative image of the exercises. Further details included in this booklet will include, information regarding the benefits of exercise including walking and safety measures in undertaking the exercises.

Sports Exercise Instructor led Chair-based Exercise Programme Patients will be given Sports Exercise Instructor led training on how to perform the chair-based exercises, for 6 weeks. This will be delivered during one of the patients' dialysis sessions. The Instructor will deliver a short 10 minute session to patients and deliver safety instruction.

Motivational interviewing Motivational interviewing will consist of discussion to encourage the participant without coercion and help them develop goals.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford Brookes University

OTHER

Sponsor Role: lead

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Responsible Party

Helen Dawes

Director Centre for Movement, Occupational and Rehabilitation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Dawes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

Oxford University Hospitals NHS FT

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

19/EM/0042

Identifier Type: OTHER

Identifier Source: secondary_id

201762

Identifier Type: -

Identifier Source: org_study_id