NCT05151666

Exercise in Dialysis

Assessing the Impact of Intra-dialytic Exercise Regimen on Depression Scores

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-02
• Primary completion: 2024-03-11
• Completion: 2024-05-20
• First posted: 2021-12-09
• Last updated: 2024-02-12

Locations

2 sites across 1 country: United States