Clinical trial NCT05151666: Exercise in Dialysis
Official title: Assessing the Impact of Intra-dialytic Exercise Regimen on Depression Scores
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Hemodialysis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pre-post intervention study design
Primary purpose: OTHER

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).


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)

Primary outcomes:
measure: Change in Beck Depression Inventory (BDI) Score
timeFrame: Week 1, Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Bethpage
country: United States
facility: NYU Dialysis Center of Bethpage
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Dialysis Center - Outpatient
state: New York
Study officials:
affiliation: NYU Langone Health
name: Naveed Masani, MD
role: PRINCIPAL_INVESTIGATOR
References: