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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05151666
Other study ID # 21-00989
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2, 2024
Est. completion date May 20, 2024

Study information

Verified date February 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 20, 2024
Est. primary completion date March 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. greater than 18 years of age 2. male or female 3. ESKD on maintenance hemodialysis for 3 consecutive months 4. adequate dialysis clearances (Kt/V greater than 1.2), 5. able to participate in exercise program based on nephrologist evaluation 6. able to provide written informed consent for participation, 7. Compliance with dialysis treatment regimen (attended 75% of ordered dialysis treatments in the last 3 months. Exclusion Criteria: 1. less than 18 years old 2. on hemodialysis for < 3 consecutive months 3. acute Kidney Injury diagnosis 4. patients deemed clinically unstable by Nephrologist 5. active foot ulcer 6. unable to provide written consent 7. refusal of participation 8. lower limb amputations 9. patients with dementia or severe cognitive impairment 10. patients with Psychiatric disorders (who are not treated and unstable) 11. pregnancy 12. myocardial infarction in the last 6 months 13. uncontrolled diabetes 14. patients on chronic Midodrine therapy for intradialytic blood pressure support. 15. deep vein thrombosis 16. symptomatic peripheral vascular disease and/or recent lower extremities vascular intervention (i.e. bypass)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray
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.

Locations

Country Name City State
United States NYU Dialysis Center of Bethpage Bethpage New York
United States NYU Winthrop Dialysis Center - Outpatient Mineola New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 1, Week 10
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