DepressionNCT05151666
Exercise in Dialysis
A study testing Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray in people with Depression, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of the proposed clinical trial is to support intradialytic pedal cycling exercise as an intervention and show its effect on depression and how there is a need for more programs to support this. This is an exploratory single arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2024to 20 May 2024
- 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
- greater than 18 years of age
- male or female
- ESKD on maintenance hemodialysis for 3 consecutive months
- adequate dialysis clearances (Kt/V greater than 1.2),
- able to participate in exercise program based on nephrologist evaluation
- able to provide written informed consent for participation,
- Compliance with dialysis treatment regimen (attended 75% of ordered dialysis treatments in the last 3 months.
Who cannot join
- less than 18 years old
- on hemodialysis for < 3 consecutive months
- acute Kidney Injury diagnosis
- patients deemed clinically unstable by Nephrologist
- active foot ulcer
- unable to provide written consent
Show all 16Show fewer
- refusal of participation
- lower limb amputations
- patients with dementia or severe cognitive impairment
- patients with Psychiatric disorders (who are not treated and unstable)
- pregnancy
- myocardial infarction in the last 6 months
- uncontrolled diabetes
- patients on chronic Midodrine therapy for intradialytic blood pressure support.
- deep vein thrombosis
- symptomatic peripheral vascular disease and/or recent lower extremities vascular intervention (i.e. bypass)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Dialysis Center of Bethpage
Bethpage, New York, 11714
NYU Winthrop Dialysis Center - Outpatient
Mineola, New York, 11501
About this study
Official title: Assessing the Impact of Intra-dialytic Exercise Regimen on Depression Scores
The purpose of the proposed clinical trial is to support intradialytic pedal cycling exercise as an intervention and show its effect on depression and how there is a need for more programs to support this. This is an exploratory single arm study. These patients will be cycling during dialysis treatment by using a graded duration model. Even though patients on hemodialysis (HD) have an increased life span due to renal replacement therapy, exercise can have a remarkable effect on their ability to perform daily activities. Dialysis has been shown to reduce self-confidence, increase social isolation, and cause feelings of disappointment in the future. This population faces mental and psychological stress due to the disease burden. Short-term supervised cycling programs while patients are receiving dialysis have been reported to induce systematic improvements for depression and anxiety. Exercise during hemodialysis is an effective way to reduce depressive symptoms without using pharmacologic measures.
Data for each patient will be collected at each dialysis treatment using a unique patient identifier. The data that will be collected include duration of exercise (intermittent or continuous), any complications during HD, vital signs while cycling every 30 minutes, and how they state they feel after cycling. The measurable outcome will be depression scores. The tool that will be used for this project is the Beck Depression Inventory (BDI). The patient will complete the BDI assessment on week 1 (pre intervention as baseline) and then on week 10 (post intervention).
- Conditions
- Depression
- Being tested
- Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray
- Keywords
- Hemodialysis
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 GrayOther
The intervention will be that the patient cycles in a sitting position within the first 2 hours of hemodialysis treatment for 15-60 minutes/as tolerated, either intermittent/continuous duration. - Graded duration will increase every 2 weeks. This will be supervised by a dialysis nurse as per the schedule of study assessments.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | Experimental | Not described Receives: Other: Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory (BDI) Score
BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score > 40 indicates extreme depression.
Measured: Week 1, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start2 Feb 2024 (estimated)
- Primary completion11 Mar 2024 (estimated)
- Study completion20 May 2024 (estimated)
Why it stopped: Initially the study failed to start due to Covid concerns. As this is an immunocompromised patient population, this concern has persisted and study initiation was further complicated by a demographic and availability change in research team members.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pre-post intervention study design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naveed Masani, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151666
- Sponsor's protocol ID
- 21-00989
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Intra-dialytic Exercise Regimen on Depression Scores
- ClinicalTrials.gov ID
- NCT05151666
- Acronym / sponsor ID
- 21-00989
- Conditions
- Depression
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Initially the study failed to start due to Covid concerns. As this is an immunocompromised patient population, this concern has persisted and study initiation was further complicated by a demographic and availability change in research team members.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 2 Feb 2024 (estimated)
- Primary completion
- 11 Mar 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 9 Dec 2021 (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.
The purpose of the proposed clinical trial is to support intradialytic pedal cycling exercise as an intervention and show its effect on depression and how there is a need for more programs to support this. This is an exploratory single arm study. These patients will be cycling during dialysis treatment by using a graded duration model. Even though patients on hemodialysis (HD) have an increased life span due to renal replacement therapy, exercise can have a remarkable effect on their ability to perform daily activities. Dialysis has been shown to reduce self-confidence, increase social isolation, and cause feelings of disappointment in the future. This population faces mental and psychological stress due to the disease burden. Short-term supervised cycling programs while patients are receiving dialysis have been reported to induce systematic improvements for depression and anxiety. Exercise during hemodialysis is an effective way to reduce depressive symptoms without using pharmacologic measures.
Data for each patient will be collected at each dialysis treatment using a unique patient identifier. The data that will be collected include duration of exercise (intermittent or continuous), any complications during HD, vital signs while cycling every 30 minutes, and how they state they feel after cycling. The measurable outcome will be depression scores. The tool that will be used for this project is the Beck Depression Inventory (BDI). The patient will complete the BDI assessment on week 1 (pre intervention as baseline) and then on week 10 (post intervention).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pre-post intervention study design
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | Experimental | Other: Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- greater than 18 years of age
- male or female
- ESKD on maintenance hemodialysis for 3 consecutive months
- adequate dialysis clearances (Kt/V greater than 1.2),
- able to participate in exercise program based on nephrologist evaluation
Key exclusion criteria (16 listed)
- less than 18 years old
- on hemodialysis for < 3 consecutive months
- acute Kidney Injury diagnosis
- patients deemed clinically unstable by Nephrologist
- active foot ulcer
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 |
|---|---|---|
| Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 GrayThe intervention will be that the patient cycles in a sitting position within the first 2 hours of hemodialysis treatment for 15-60 minutes/as tolerated, either intermittent/continuous duration. - Graded duration will increase every 2 weeks. This will be supervised by a dialysis nurse as per the schedule of study assessments. | Other | Hemodialysis Patients |
Primary outcome
Change in Beck Depression Inventory (BDI) Score
Time frame: Week 1, Week 10
BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score > 40 indicates extreme depression.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Naveed Masani, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray in people with Depression, run by NYU Langone Health at 2 sites in United States.
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 16 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: withdrawn, as of the sponsor's last update on 12 Feb 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Beck Depression Inventory (BDI) Score (time frame: Week 1, Week 10). 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 12 Feb 2024.