End-Stage Renal DiseasePhase 2NCT02754271
Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
A Phase 2 study testing Fit for Dialysis in people with End-Stage Renal Disease, run by Toronto Rehabilitation Institute at 2 sites in Canada.
Trial summary
Exercise training for older hemodialysis patients can greatly improve many of the negative effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet to be incorporated effectively and systematically into routine care. Exercise programs remain rare. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Fit for Dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2014to Mar 2017
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have conversational ability in English
- Have a medical diagnosis of hemodialysis-dependent end-stage renal disease
- Are a registered hemodialysis patient in the hospital for at least 3 months
- Receive ≥ 2 in-centre hemodialysis sessions per week
- Are ambulatory (with or without aids)
- Are deemed medically eligible by their nephrologist to participate in an exercise program that includes stretching, strengthening, and cardiovascular components
- Have a family caregiver who agrees to participate in the exercise program and keep a log of exercises on non-dialysis days
Who cannot join
- Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Humber River Hospital - Wilson Site
Toronto, Ontario, M3M 0B2
- Active, not recruiting
St. Joseph's Health Centre - Satellite Site
Toronto, Ontario, M8Z 6A4
About this study
Exercise training for older hemodialysis patients can greatly improve many of the negative effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet to be incorporated effectively and systematically into routine care. Exercise programs remain rare. When such programs are implemented, their participation rates vary, and they neglect home and community-based activities, as well as the involvement of family caregivers to support and reinforce exercise. This study is intended to address these limitations by introducing a highly accessible and compelling educational film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by family caregivers, nephrologists, and nurses. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise-based principles of wellness in the context of end-stage renal disease. Ultimately Fit for Dialysis could be used as a model for dialysis education that supports guideline recommendations that exercise be incorporated into the care and treatment of dialysis patients.
Read the detailed description
The study introduces a highly accessible and compelling educational film designed to introduce, motivate, and sustain patient exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrology staff and family caregivers. Fit for Dialysis is a filmed drama that is based on focus group research with older hemodialysis patients, family caregivers, and health care practitioners that highlighted patients' desire to exercise as well as discouragement of patients to do so by overprotective families, and nurses' preferences for patient sedentariness during hemodialysis. Fit for Dialysis was tailored to the exigencies of out-patient hemodialysis settings by acknowledging and providing a roadmap to overcome the disciplinary silos and paternalism towards patients which inhibit exercise during hemodialysis, and highlighting some of the life circumstances that may influence patients' self-management of exercise behaviours at home and in the community.
In order to advance our understanding of the ways in which Fit for Dialysis influences participant outcomes, a prospective 2-site parallel intervention trial will be implemented that will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Each hospital will have a 12-week follow-up. Qualitative and quantitative methods will be used including semi-structured interviews, and physical fitness and activity measures. These data will be used to explore the impact of Fit for Dialysis on: the knowledge/attitudes of patients, family caregivers, and staff regarding exercise-based principles of wellness; the education, motivation, or maintenance of patient exercise during dialysis, at home, and in the community; adherence to exercise prescription; and patient physical fitness and activity outcomes. The study will also explore factors related to family caregivers, nephrologists, nurses, and hospital administrators, and patients' home and community environments that may impact the successful uptake of the key messages of Fit for Dialysis.
In the intervention site (film+exercise hospital), 30 patients will view Fit for Dialysis and participate in the exercise program; at the exercise-only hospital, 30 patients will only exercise. A family caregiver of each participating patient will either view Fit for Dialysis and read an information letter on the benefits and contraindications of exercise (in the film+exercise hospital), or will only read the information letter (in the exercise-only hospital). In the film+exercise hospital, five nephrologists, 10 nurses and 3 administrators will also view the film. In both hospitals, 10 patients, 10 family caregivers, 10 nurses, 5 nephrologists, 3 administrators, and the physiotherapist assistants will be interviewed.
- Conditions
- End-Stage Renal Disease
- Being tested
- Fit for Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit for DialysisOther
A 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community. Receives: Other: Fit for Dialysis |
| Control | No intervention | The 16-week exercise program involving activities during dialysis, at home, and in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Measured: 1-16 weeks
Change in functional exercise capacity measured by the 2-Minute Walk Test
Measured: 0, 8, 16, 28 weeks
Secondary outcomes (5)
Change in number of steps using a pedometer
Measured: 0, 8, 16, 28 weeks
Change in basic mobility using the Timed Up and Go
Measured: 0, 8, 16, 28 weeks
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Measured: 0, 8, 16, 28 weeks
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Measured: 0, 8, 16, 28 weeks
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Measured: 1-16, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Pia Kontos, Toronto Rehabilitation Institute
- Investigators
- Pia Kontos, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754271
- Sponsor's protocol ID
- 14-7507-DE
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kontos P, Grigorovich A, Colobong R, Miller KL, Nesrallah GE, Binns MA, Alibhai SMH, Parsons T, Jassal SV, Thomas A, Naglie G. Fit for Dialysis: a qualitative exploration of the impact of a research-based film for the promotion of exercise in hemodialysis. BMC Nephrol. 2018 Aug 6;19(1):195. doi: 10.1186/s12882-018-0984-4.
PubMed 30081845Kontos P, Alibhai SM, Miller KL, Brooks D, Colobong R, Parsons T, Jassal SV, Thomas A, Binns M, Naglie G. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients. BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
PubMed 28122510
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
- ClinicalTrials.gov ID
- NCT02754271
- Acronym / sponsor ID
- 14-7507-DE
- Conditions
- End-Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Exercise training for older hemodialysis patients can greatly improve many of the negative effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet to be incorporated effectively and systematically into routine care. Exercise programs remain rare. When such programs are implemented, their participation rates vary, and they neglect home and community-based activities, as well as the involvement of family caregivers to support and reinforce exercise. This study is intended to address these limitations by introducing a highly accessible and compelling educational film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by family caregivers, nephrologists, and nurses. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise-based principles of wellness in the context of end-stage renal disease. Ultimately Fit for Dialysis could be used as a model for dialysis education that supports guideline recommendations that exercise be incorporated into the care and treatment of dialysis patients.
Detailed description
The study introduces a highly accessible and compelling educational film designed to introduce, motivate, and sustain patient exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrology staff and family caregivers. Fit for Dialysis is a filmed drama that is based on focus group research with older hemodialysis patients, family caregivers, and health care practitioners that highlighted patients' desire to exercise as well as discouragement of patients to do so by overprotective families, and nurses' preferences for patient sedentariness during hemodialysis. Fit for Dialysis was tailored to the exigencies of out-patient hemodialysis settings by acknowledging and providing a roadmap to overcome the disciplinary silos and paternalism towards patients which inhibit exercise during hemodialysis, and highlighting some of the life circumstances that may influence patients' self-management of exercise behaviours at home and in the community.
In order to advance our understanding of the ways in which Fit for Dialysis influences participant outcomes, a prospective 2-site parallel intervention trial will be implemented that will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Each hospital will have a 12-week follow-up. Qualitative and quantitative methods will be used including semi-structured interviews, and physical fitness and activity measures. These data will be used to explore the impact of Fit for Dialysis on: the knowledge/attitudes of patients, family caregivers, and staff regarding exercise-based principles of wellness; the education, motivation, or maintenance of patient exercise during dialysis, at home, and in the community; adherence to exercise prescription; and patient physical fitness and activity outcomes. The study will also explore factors related to family caregivers, nephrologists, nurses, and hospital administrators, and patients' home and community environments that may impact the successful uptake of the key messages of Fit for Dialysis.
In the intervention site (film+exercise hospital), 30 patients will view Fit for Dialysis and participate in the exercise program; at the exercise-only hospital, 30 patients will only exercise. A family caregiver of each participating patient will either view Fit for Dialysis and read an information letter on the benefits and contraindications of exercise (in the film+exercise hospital), or will only read the information letter (in the exercise-only hospital). In the film+exercise hospital, five nephrologists, 10 nurses and 3 administrators will also view the film. In both hospitals, 10 patients, 10 family caregivers, 10 nurses, 5 nephrologists, 3 administrators, and the physiotherapist assistants will be interviewed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fit for DialysisA research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community. |
| Control | No intervention | –The 16-week exercise program involving activities during dialysis, at home, and in the community. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Have conversational ability in English
- Have a medical diagnosis of hemodialysis-dependent end-stage renal disease
- Are a registered hemodialysis patient in the hospital for at least 3 months
- Receive ≥ 2 in-centre hemodialysis sessions per week
- Are ambulatory (with or without aids)
Key exclusion criteria (1 listed)
- Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session
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 |
|---|---|---|
| Fit for DialysisA 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community. | Other | Intervention |
Primary outcome
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Time frame: 1-16 weeks
Change in functional exercise capacity measured by the 2-Minute Walk Test
Time frame: 0, 8, 16, 28 weeks
5 secondary outcomes
Change in number of steps using a pedometer
Time frame: 0, 8, 16, 28 weeks
Change in basic mobility using the Timed Up and Go
Time frame: 0, 8, 16, 28 weeks
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Time frame: 0, 8, 16, 28 weeks
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Time frame: 0, 8, 16, 28 weeks
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Time frame: 1-16, 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Derived from this study: PubMed 30081845Kontos P, Grigorovich A, Colobong R, Miller KL, Nesrallah GE, Binns MA, Alibhai SMH, Parsons T, Jassal SV, Thomas A, Naglie G. Fit for Dialysis: a qualitative exploration of the impact of a research-based film for the promotion of exercise in hemodialysis. BMC Nephrol. 2018 Aug 6;19(1):195. doi: 10.1186/s12882-018-0984-4.
- Derived from this study: PubMed 28122510Kontos P, Alibhai SM, Miller KL, Brooks D, Colobong R, Parsons T, Jassal SV, Thomas A, Binns M, Naglie G. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients. BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
- Individual participant dataSharing planned: No
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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.
Pia Kontos, PhD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fit for Dialysis in people with End-Stage Renal Disease, run by Toronto Rehabilitation Institute at 2 sites in Canada.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pia Kontos, PhD (416-597-3422 ext. 7609, pia.kontos@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week. (time frame: 1-16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754271, which also lists 2 linked publications.
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 28 Apr 2016.