DiabetesPhase 2NCT03076528
An Innovative Virtually Supervised Exercise for Dialysis Patients
A Phase 2 study testing Sensor-based interactive exercise (game-based exercise) and Non-technology foot and ankle exercise program in people with Diabetes and Chronic Kidney Failure, run by Baylor College of Medicine at 1 site in Qatar.
Trial summary
Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Furthermore, in diabetics with end stage renal disease (ESRD) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes, Chronic Kidney Failure, Hemodialysis Complication
- What is being tested?
- Sensor-based interactive exercise (game-based exercise) and Non-technology foot and ankle exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 6 Nov 2016to 6 Feb 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of 50 years or older, who are undergoing hemodialysis process
- Patients in diabetes
- Ability to provide consent
Who cannot join
- Non-ambulatory patients (unable to walk independently a distance of 20m with or without existence)
- Active foot ulcer
- Major foot amputation
- Charcot neuroarthropathy
- Major hearing/vision impaired
- Any patient with changes in psychotropic or sleep medications in the last 6 weeks
- Patients concurrently participating in another exercise training
- Patients with any clinically significant medical or psychiatric condition, or laboratory abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Furthermore, in diabetics with end stage renal disease (ESRD) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in patients with dialysis has been reported to be same as with patients with history of foot ulcers; dialysis patients have significantly higher rate of foot amputation.
The goal of this research is to incorporate an innovative virtually supervised non-weight bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration by enhancing lower extremity blood flow, joint perception and joint mobility.
Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 4-week non-weight bearing exercise program twice per week at the hemodialysis clinic under the supervision of a qualified research staff member. This intervention includes interactive game-based exercises including repetitive ankle and foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, incidence of foot problems will be compared pre- and post-intervention. In addition, the incident of falls, foot ulcers, and limb amputation up to 6 months post intervention will be documented. Investigators hypothesize that patients receiving sensor-based exercises will benefit more compared to group receiving conventional non-technology training in terms of improving functional performance and reducing incidence of foot problems, falls, and limb amputation.
- Conditions
- Diabetes, Chronic Kidney Failure, Hemodialysis Complication
- Being tested
- Sensor-based interactive exercise (game-based exercise), Non-technology foot and ankle exercise program
- Keywords
- exercise, exergame, hemodialysis, balance
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-based interactive exercise (game-based exercise)Other
This intervention includes interactive game-based lower extremity training including repetitive ankle movements in multiple directions. Wearable sensors will provide real-time feedback from foot and ankle position and allow perception of motor-errors during each motor-action
Non-technology foot and ankle exercise programOther
Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with game-based exercise | Experimental | Subjects will be receiving sensor-based interactive ankle \& foot exercise program (game-based exercise) during hemo-dialysis, approximately 30 minutes, twice per week and for 4 weeks. Receives: Other: Sensor-based interactive exercise (game-based exercise) |
| Non-technology foot and ankle exercise program | Active comparator | Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks. Receives: Other: Non-technology foot and ankle exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed change from Baseline to 4 weeks
walking ability is quantified by gait speed
Measured: Baseline and 4 weeks
Balance change from Baseline to 4 weeks quantified by body sway
Balance is quantified by body sway
Measured: Baseline and 4 weeks
Secondary outcomes (4)
Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Measured: Baseline and 4 weeks
Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire
Measuring depression using Center of Epidemiologic Depression Scale (CES-D) questionnaire
Measured: Baseline to 4 weeks
Change of Incident of falls
Measured: Baseline and 6 months
Change of Incidents of foot problems
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start6 Nov 2016
- Primary completion6 Jan 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation, Qatar National Research Fund
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076528
- Sponsor's protocol ID
- H-38522
- Status last verified
- May 2019
- First submitted
- 7 Mar 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
Publications
Zhou H, Al-Ali F, Rahemi H, Kulkarni N, Hamad A, Ibrahim R, Talal TK, Najafi B. Hemodialysis Impact on Motor Function beyond Aging and Diabetes-Objectively Assessing Gait and Balance by Wearable Technology. Sensors (Basel). 2018 Nov 14;18(11):3939. doi: 10.3390/s18113939.
PubMed 30441843
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Virtually Supervised Exercise for Dialysis Patients
- ClinicalTrials.gov ID
- NCT03076528
- Acronym / sponsor ID
- H-38522
- Conditions
- Diabetes, Chronic Kidney Failure, Hemodialysis Complication
- Keywords
- exercise, exergame, hemodialysis, balance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation, Qatar National Research Fund
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 10 Mar 2017 (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.
Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Furthermore, in diabetics with end stage renal disease (ESRD) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in patients with dialysis has been reported to be same as with patients with history of foot ulcers; dialysis patients have significantly higher rate of foot amputation.
The goal of this research is to incorporate an innovative virtually supervised non-weight bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration by enhancing lower extremity blood flow, joint perception and joint mobility.
Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 4-week non-weight bearing exercise program twice per week at the hemodialysis clinic under the supervision of a qualified research staff member. This intervention includes interactive game-based exercises including repetitive ankle and foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, incidence of foot problems will be compared pre- and post-intervention. In addition, the incident of falls, foot ulcers, and limb amputation up to 6 months post intervention will be documented. Investigators hypothesize that patients receiving sensor-based exercises will benefit more compared to group receiving conventional non-technology training in terms of improving functional performance and reducing incidence of foot problems, falls, and limb amputation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with game-based exercise | Experimental | Other: Sensor-based interactive exercise (game-based exercise)Subjects will be receiving sensor-based interactive ankle \& foot exercise program (game-based exercise) during hemo-dialysis, approximately 30 minutes, twice per week and for 4 weeks. |
| Non-technology foot and ankle exercise program | Active comparator | Other: Non-technology foot and ankle exercise programSubjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of 50 years or older, who are undergoing hemodialysis process
- Patients in diabetes
- Ability to provide consent
Key exclusion criteria (8 listed)
- Non-ambulatory patients (unable to walk independently a distance of 20m with or without existence)
- Active foot ulcer
- Major foot amputation
- Charcot neuroarthropathy
- Major hearing/vision impaired
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 |
|---|---|---|
| Sensor-based interactive exercise (game-based exercise)This intervention includes interactive game-based lower extremity training including repetitive ankle movements in multiple directions. Wearable sensors will provide real-time feedback from foot and ankle position and allow perception of motor-errors during each motor-action | Other | Intervention with game-based exercise |
| Non-technology foot and ankle exercise programSubjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension. | Other | Non-technology foot and ankle exercise program |
Primary outcome
Gait Speed change from Baseline to 4 weeks
Time frame: Baseline and 4 weeks
walking ability is quantified by gait speed
Balance change from Baseline to 4 weeks quantified by body sway
Time frame: Baseline and 4 weeks
Balance is quantified by body sway
4 secondary outcomes
Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire
Time frame: Baseline and 4 weeks
Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire
Time frame: Baseline to 4 weeks
Change of Incident of falls
Time frame: Baseline and 6 months
Change of Incidents of foot problems
Time frame: Baseline and 6 months
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 6 May 2019.
- Results publication: PubMed 30441843Zhou H, Al-Ali F, Rahemi H, Kulkarni N, Hamad A, Ibrahim R, Talal TK, Najafi B. Hemodialysis Impact on Motor Function beyond Aging and Diabetes-Objectively Assessing Gait and Balance by Wearable Technology. Sensors (Basel). 2018 Nov 14;18(11):3939. doi: 10.3390/s18113939.
- Individual participant dataSharing planned: Undecided. Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sensor-based interactive exercise (game-based exercise) and Non-technology foot and ankle exercise program in people with Diabetes and Chronic Kidney Failure, run by Baylor College of Medicine at 1 site in Qatar.
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 3 inclusion and 8 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 6 May 2019. 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 Qatar. 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?
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?
Gait Speed change from Baseline to 4 weeks (time frame: Baseline and 4 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 NCT03076528, which also lists 1 linked publication.
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 6 May 2019.