Exercise in Dialysis

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).

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Other: Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bethpage, New York, United States, 11714
      • NYU Dialysis Center of Bethpage
    • Mineola, New York, United States, 11501
      • NYU Winthrop Dialysis Center - Outpatient

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hemodialysis Patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Naveed Masani, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2024
• Primary Completion (Estimated): March 11, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 21-00989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No