Exercise in Dialysis

NCT ID: NCT05151666

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-05-20

Brief 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).

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hemodialysis Patients

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naveed Masani, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Dialysis Center of Bethpage

Bethpage, New York, United States

NYU Winthrop Dialysis Center - Outpatient

Mineola, New York, United States

Countries

United States

Other Identifiers

21-00989

Identifier Type: -

Identifier Source: org_study_id