Physical Activity in Haemodialysis Patients: a Feasibility Study

NCT04103177 | Completed

• 2 other identifiers: 20176219/EM/0042
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change is being assessed 3 metre Timed Up and Go

  Change from baseline functional mobility at 6 months

• Change is being assessed 10 metre walk test

  Change from baseline functional mobility at 6 months

• Change is being assessed Hand grip strength

  Change from baseline arm strength at 6 months

• Change is being assessed Wrist worn accelerometery data

  Change from baseline of activity at 6 months

• Change is being assessed EQ-5D-3L questionnaire

  Change from baseline quality of life at 6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Chair based exercises in the dialysis environment 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford Brookes University: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Oxford University Hospitals NHS FT

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Study Officials

• Helen Dawes, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Centre for Movement, Occupational and Rehabilitation Sciences

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 25, 2019
• Study Start: September 23, 2019
• Primary Completion: April 27, 2020
• Study Completion: May 29, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

GB (1)