NCT04525196

Brief Summary

Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases. The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away. Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients. With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

4.5 years

First QC Date

July 29, 2020

Last Update Submit

October 18, 2023

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (2)

  • The clinical impact of a physical activity program on the walking capacity.

    Measure and evolution of the performance to the 6 minutes walking test.

    Baseline.

  • The clinical impact of a physical activity program on the walking capacity.

    Measure and evolution of the performance to the 6 minutes walking test.

    6 months after the inclusion.

Secondary Outcomes (25)

  • The clinical impact of a 12 month physical activity program on the aeroby capacity of the patients.

    At the randomization visit, and 12 months after the inclusion.

  • The clinical impact of a physical activity program on the muscle binding.

    At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.

  • The clinical impact of a physical activity program on the muscle binding.

    At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.

  • The clinical impact of a physical activity program on the muscle binding.

    At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.

  • The clinical impact of a physical activity program on the muscle binding.

    At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.

  • +20 more secondary outcomes

Study Arms (2)

Physical activity.

EXPERIMENTAL

Patients will benefit a physical activity program during their dialysis session.

Other: Physical activity.

No physical activity.

NO INTERVENTION

Patients will have access to their dialysis sessions without additional physical activity.

Interventions

Physical activity.OTHER

The procedure under study (physical activity program) will include, each week for 12 months, two sessions dedicated to the development of aerobic capacity and a muscle building session. The experimental group will therefore be offered 3 sessions of Physical Activity (PA) per week. The PA will be positioned in the first two hours after the start of the dialysis session. Each session will include 5 minutes of general warm-up, then 15 minutes of PA itself and finally 5 minutes of cool down period. The PA time itself will be increased as the sessions progress, according to the progress and improvement of physical capabilities of patients.

Physical activity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 or over.
  • Patient on hemodialysis.
  • Patient in sufficient clinical condition allowing performing physical activity sessions during dialysis, according to the judgment of the investigator.
  • Patient who was informed of the study and who gave his informed consent.
  • Patient benefiting from a mandatory social security.

You may not qualify if:

  • Recent myocardial infarction (\<1 month).
  • Rheumatological pathology which does not allow pedaling.
  • Unmatched amputation of the lower limbs.
  • Patients under legal protection.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Bouchard

Marseille, 13006, France

RECRUITING

Polyclinique les Fleurs

Ollioules, 83190, France

RECRUITING

Related Publications (15)

  • Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.

    PMID: 21177953BACKGROUND

  • Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111/j.1476-5381.2012.01970.x.

    PMID: 22486393BACKGROUND

  • Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24. doi: 10.1111/j.1523-1755.2004.00411.x.

    PMID: 14717947BACKGROUND

  • Kopple JD, Kim JC, Shapiro BB, Zhang M, Li Y, Porszasz J, Bross R, Feroze U, Upreti R, Kalantar-Zadeh K. Factors affecting daily physical activity and physical performance in maintenance dialysis patients. J Ren Nutr. 2015 Mar;25(2):217-22. doi: 10.1053/j.jrn.2014.10.017.

    PMID: 25701942BACKGROUND

  • Panaye M, Kolko-Labadens A, Lasseur C, Paillasseur JL, Guillodo MP, Levannier M, Teta D, Fouque D. Phenotypes influencing low physical activity in maintenance dialysis. J Ren Nutr. 2015 Jan;25(1):31-9. doi: 10.1053/j.jrn.2014.07.010. Epub 2014 Oct 8.

    PMID: 25304464BACKGROUND

  • Matsuzawa R, Roshanravan B, Shimoda T, Mamorita N, Yoneki K, Harada M, Watanabe T, Yoshida A, Takeuchi Y, Matsunaga A. Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. J Ren Nutr. 2018 Jan;28(1):45-53. doi: 10.1053/j.jrn.2017.07.004. Epub 2017 Sep 8.

    PMID: 28893466BACKGROUND

  • Matsuzawa R, Matsunaga A, Wang G, Kutsuna T, Ishii A, Abe Y, Takagi Y, Yoshida A, Takahira N. Habitual physical activity measured by accelerometer and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol. 2012 Dec;7(12):2010-6. doi: 10.2215/CJN.03660412. Epub 2012 Sep 13.

    PMID: 22977216BACKGROUND

  • Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.

    PMID: 23124787BACKGROUND

  • Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7.

    PMID: 24913219BACKGROUND

  • Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.

    PMID: 27909047BACKGROUND

  • Olvera-Soto MG, Valdez-Ortiz R, Lopez Alvarenga JC, Espinosa-Cuevas Mde L. Effect of Resistance Exercises on the Indicators of Muscle Reserves and Handgrip Strength in Adult Patients on Hemodialysis. J Ren Nutr. 2016 Jan;26(1):53-60. doi: 10.1053/j.jrn.2015.06.006. Epub 2015 Aug 8.

    PMID: 26264173BACKGROUND

  • Isnard-Rouchon M, Coutard C. [Exercise as a protective cardiovascular and metabolic factor in end stage renal disease patients]. Nephrol Ther. 2017 Dec;13(7):544-549. doi: 10.1016/j.nephro.2017.01.027. Epub 2017 Nov 7. French.

    PMID: 29126841BACKGROUND

  • Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.

    PMID: 25278548BACKGROUND

  • Matsuzawa R, Aoyama N, Yoshida A. Clinical Characteristics of Patients on Hemodialysis With Peripheral Arterial Disease. Angiology. 2015 Nov;66(10):911-7. doi: 10.1177/0003319715572678. Epub 2015 Feb 18.

    PMID: 25694516BACKGROUND

  • Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.

    PMID: 27851991BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Valérie Masson, MD

CONTACT

(0)6 13 62 66 23vmasson.nephro@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 25, 2020

Study Start

January 29, 2021

Primary Completion

July 29, 2025

Study Completion

July 29, 2025

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)