Chronic Intradialytic Exercise : a Cardioprotective Role

NCT04697459 | Completed

• 1 other identifier: 2020-09-14
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

Conditions

Chronic Renal Failure

Keywords

exercise; hemodialysis

Outcome Measures

Primary Outcomes (6)

• Changes in myocardial longitudinal deformations

  Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

• Changes in myocardial longitudinal deformations

  Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

• Changes in myocardial circumferential deformations

  Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

• Changes in myocardial circumferential deformations

  Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

• Changes in left ventricular torsion

  Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

• Changes in left ventricular torsion

  Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.

  Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

Secondary Outcomes (4)

• Changes in arterial rigidity

  before (week 0) and after (week 17) an exercise training program of 16 weeks

• Changes in Physical fitness

  before (week 0) and after (week 17) an exercise training program of 16 weeks

• Health-related Quality of life

  before (week 0) and after (week 17) an exercise training program of 16 weeks

• Changes in carotid intimal-media wall thickness

  before (week 0) and after (week 17) an exercise training program of 16 weeks

Study Arms (2)

HD-EX (patient with intradialytic exercise)

EXPERIMENTAL

will be enrolled in a 16 week intradilatytic exercise program.

Other: chronic phase; Other: acute phase

HD (patients with standard HD)

NO INTERVENTION

patients with standard hemodialysis (e.g. without exercise).

Interventions

chronic phase OTHER

1h of intradialytic execise, starting 30 min after hemodialysis beginning : 30 min of low-intensity (Borg Scale 11-14) aerobic exercise + 30 min of resistance training, frequency : 3 times a week for 16 weeks.

HD-EX (patient with intradialytic exercise)

acute phase OTHER

30 min of low-intensity (Borg Scale 11-14) aerobic exercise, starting 30 min after hemodialysis beginning

HD-EX (patient with intradialytic exercise)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No medical contraindication to physical activity
• Life expectancy greater than 6 months
• Patients on haemodialysis for more than 3 months

You may not qualify if:

• Pregnancy
• Valvular heart disease,
• Unstable coronary artery disease
• Arteriopathy obliterating of the lower limbs stage III and IV
• Musculoskeletal problems
• Severe respiratory disease
• BMI\> 35
• Pacemaker, cardiac stimulation and automatic implantable defibrillator
• Heart transplant
• Uncontrolled arterial hypertension
• Ejection fraction \<45%

Sponsors & Collaborators

• University of Avignon: lead

Study Sites (2)

Centre Hemodialyse AIDER sante

Nîmes, Gard, 30029, France

Location

ATIR

Avignon, Vaucluse, 84000, France

Location

Related Publications (1)

• Josse M, Patrier L, Isnard M, Turc-Baron C, Grandperrin A, Nottin S, Mandigout S, Cristol JP, Maufrais C, Obert P. Cardioprotective Effect of Acute Intradialytic Exercise: A Comprehensive Speckle-Tracking Echocardiography Analysis. J Am Soc Nephrol. 2023 Aug 1;34(8):1445-1455. doi: 10.1681/ASN.0000000000000149. Epub 2023 Apr 18.

  PMID: 37071035 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Philippe Obert, Pr.

  Avignon University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Acute phase : standard HD versus HD with acute intradialytic exercise (in HD-EX group only); * Chronic phase : before and after an exercise training program of 16 weeks (HD-EX group) as well as before and after 16 weeks of standard HD (HD group)

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 6, 2021
• Study Start: December 13, 2020
• Primary Completion: May 14, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)