End Stage Renal Failure on DialysisPA-CKDNCT04103177
Physical Activity in Haemodialysis Patients: a Feasibility Study
A study testing Chair based exercises in the dialysis environment in people with End Stage Renal Failure on Dialysis, run by Oxford Brookes University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Chair based exercises in the dialysis environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2019to 29 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS FT
Oxford, Oxfordshire, OX3 7LE
About this study
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.
Read the 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
- Being tested
- Chair based exercises in the dialysis environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chair based exercises in the dialysis environmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chair based exercises in the dialysis environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi structured interviews and questionnaires targeted to determine participant acceptability of PA intervention and the people delivering it
Interviews with patients and staff
Measured: 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
Functional activity, 1 minute to complete
Measured: Change from baseline functional mobility at 6 months
Change is being assessed 10 metre walk test
Functional activity, 5 minutes to complete
Measured: Change from baseline functional mobility at 6 months
Change is being assessed Hand grip strength
Functional strength, 2 minutes to complete.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start23 Sep 2019
- Primary completion27 Apr 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Helen Dawes, Oxford Brookes University
- Investigators
- Helen Dawes, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103177
- Sponsor's protocol ID
- 201762
- Other IDs
- 19/EM/0042
- Acronym
- PA-CKD
- Status last verified
- Apr 2022
- First submitted
- 19 Sep 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Exercise and Educational Intervention to Increase Physical Activity in Haemodialysis Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04103177
- Acronym / sponsor ID
- PA-CKD / 201762
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Chair based exercises in the dialysis environment20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Participant is willing and able to give informed consent for participation in the trial.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chair based exercises in the dialysis environmentEach 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. | Other | Intervention group |
Primary outcome
Semi structured interviews and questionnaires targeted to determine participant acceptability of PA intervention and the people delivering it
Time frame: Interviews should last no longer than an hour and will be conducted at month 3 post baseline
Interviews with patients and staff
9 secondary outcomes
Change is being assessed 3 metre Timed Up and Go
Time frame: Change from baseline functional mobility at 6 months
Change is being assessed 10 metre walk test
Time frame: Change from baseline functional mobility at 6 months
Change is being assessed Hand grip strength
Time frame: Change from baseline arm strength at 6 months
Change is being assessed Wrist worn accelerometery data
Time frame: Change from baseline of activity at 6 months
Change is being assessed EQ-5D-3L questionnaire
Time frame: Change from baseline quality of life at 6 months
Change is being assessed IPOS Renal questionnaire
Time frame: Change from baseline quality of life at 6 months
Change is being assessed Human Activity profile questionnaire
Time frame: Change from baseline of physical activity at 6 months
Falls and Fractures questionnaire
Time frame: Change from baseline
Client Service Receipt Inventory Questionnaire
Time frame: Change from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Dawes, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chair based exercises in the dialysis environment in people with End Stage Renal Failure on Dialysis, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi structured interviews and questionnaires targeted to determine participant acceptability of PA intervention and the people delivering it (time frame: Interviews should last no longer than an hour and will be conducted at month 3 post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.