Physical Activity in Haemodialysis Patients: a Feasibility Study (PA-CKD)

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Failure on Dialysis
• Intervention / Treatment: Other: Chair based exercises in the dialysis environment

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Oxford University Hospitals NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi structured interviews and questionnaires targeted to determine participant acceptability of PA intervention and the people delivering it	Interviews with patients and staff	Interviews should last no longer than an hour and will be conducted at month 3 post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is being assessed 3 metre Timed Up and Go	Functional activity, 1 minute to complete	Change from baseline functional mobility at 6 months
Change is being assessed 10 metre walk test	Functional activity, 5 minutes to complete	Change from baseline functional mobility at 6 months
Change is being assessed Hand grip strength	Functional strength, 2 minutes to complete.	Change from baseline arm strength at 6 months
Change is being assessed Wrist worn accelerometery data	Accelerometers to be worn for one week at 3 time points to assess daily activity	Change from baseline of activity at 6 months
Change is being assessed EQ-5D-3L questionnaire	This is a self-completing short questionnaire comprising questions on the following 5 areas: mobility, self-care and daily activities. This should take no longer to complete.	Change from baseline quality of life at 6 months
Change is being assessed IPOS Renal questionnaire	This is self-completing questionnaire comprising of 11 questions assessing renal symptoms with other items for additional concerns. 10 minutes to complete	Change from baseline quality of life at 6 months
Change is being assessed Human Activity profile questionnaire	This tick box questionnaire consists of 94 questions and seeks to determine the activities participants currently do. 15 minutes to complete	Change from baseline of physical activity at 6 months
Falls and Fractures questionnaire	We wish to know if participants have had any falls or fractures in the last 6 months and assess baseline mobility level. Questions are based on Yes or No Referred medical falls clinic☐ Referred therapy falls clinic☐ Referred non-FLS primary care No. of falls, slips, trips in last 12 months= Indoor Gait: range from 1-2 Outdoor Gait: range from 1-2 Any Indoor falls- yes or no Broken bones in adult hood= Yes/No	Change from baseline
Client Service Receipt Inventory Questionnaire	Participants will be given as short tick-box questionnaire to collect information regarding other hospitals facilities they have visited including General Practitioner visits over the last 6 months. This will exclude routine visits to haemodialysis. Hospital departments and services used in last 6 months- No=0 Yes=1 Use of community care services in last 6 months- No=0 Yes=1 Diagnostic tests in last 6 months- No=0 Yes=1 Use of mobility aids in last 6 months- No=0 Yes=1 Adaptations at home in last 6 months-No=0 Yes=1 Changes in informal care in last 6 months months- No=0 Yes=1 Journeys to receive care in last 6 months No=0 Yes=1 Current occupation range of 1-7	Change from baseline

Collaborators and Investigators

• Sponsor: Oxford Brookes University
• Collaborators: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Helen Dawes, PhD, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): May 29, 2020

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 201762; 19/EM/0042 (Other Identifier: Research Ethics Committee- East Midlands Nottingham 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual patient data will be shared with other researchers in accordance with NHS Information Governance Policy (NHS Information Sharing Policy v2) and Oxford Brookes data sharing policies (Oxford Brookes IT policies). Plans for data sharing will be included in the data management plan, as well as the trial protocol. A data sharing statement will be included in the consent form and information provided in the patient information leaflet.

Data will be pseudonymised wherever possible prior to being shared with other researchers and the information required to "decode" this data will be stored securely elsewhere, in accordance with ICH GCP guidelines. If this is not possible then consent will be obtained from participants and approval sought from the HRA prior to the trial commencing.

• IPD Sharing Time Frame: Time frame: Once all data analysis has taken place and the core findings have been published, they will be archived securely using Arkivum (see above). Dataset preparation will be carried out by individuals with an understanding of data management and basic statistics, with quality control provided by a further individual who is independent of the process. Researchers will be able to apply to access archived data as required.

IPD Sharing Access Criteria

Once data has been archived in Arkivum, access will be granted to researchers in accordance with NHS and Oxford Brookes policies. Data access requests will be made via an application form detailing the specific requirements and the proposed research and publication plan, which will be reviewed against specific eligibility criteria by data custodians or by an external Independent Review Panel. Decisions about requests will be made promptly (no more than 3 months after receipt of request) and details of all data requests and their outcomes will be made publicly available (data requesters should be informed of this in advance of this).

Funds for responsible data sharing will be requested from trial funders as part of initial trial grant applications.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No