Last reviewed · How we verify
NCT05151666
Exercise in Dialysis
NA trial testing Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray in Depression. Withdrawn.
11 March 2024
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Start date | 2 February 2024 |
| Primary completion | 11 March 2024 |
| Estimated completion | 20 May 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray
Conditions studied
- Depression — all drugs for Depression →
Sponsor
NYU Langone Health — full company profile →
Who can join
18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05151666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Depression
Currently open trials in the same condition.
- NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
- NCT06906939 — A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression · EARLY_PHASE1 · recruiting
- NCT07517549 — Sexual Health Education During Pregnancy · NA · recruiting
- NCT06408246 — ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression · Phase 2 · recruiting
- NCT07449676 — Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression · NA · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
- NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05151666 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 12 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05151666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing