Exercise in Dialysis

NCT05151666 | Withdrawn

• 1 other identifier: 21-00989
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hemodialysis Patients

EXPERIMENTAL

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

Interventions

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

Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Dialysis Center of Bethpage

Bethpage, New York, 11714, United States

Location

NYU Winthrop Dialysis Center - Outpatient

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Naveed Masani, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pre-post intervention study design

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 9, 2021
• Study Start: February 2, 2024
• Primary Completion: March 11, 2024
• Study Completion: May 20, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Naveed.Masani@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)