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Chronic Intradialytic Exercise : a Cardioprotective Role

NCT ID: NCT04697459

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-13

Study Completion Date

2023-09-30

Brief Summary

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

Detailed Description

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Background: Hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. A deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (HD) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (HID) and myocardial stunning. The latter are now documented as direct contributors to the increased mortality observed in HD patients compared to the general population. The introduction of intradialytic physical exercise in the therapeutic program of HD patient is now recommended and practised routinely in many countries, in Scandinavia in particular. Several meta-analyses have clearly established its safety. The beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of HD patients is also clearly demonstrated. Chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. Applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during HD. However, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function.

Aims: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. The secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.

Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

* 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)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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HD-EX (patient with intradialytic exercise)

will be enrolled in a 16 week intradilatytic exercise program.

Group Type EXPERIMENTAL

chronic phase

Intervention Type 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.

acute phase

Intervention Type OTHER

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

HD (patients with standard HD)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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chronic phase

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.

Intervention Type OTHER

acute phase

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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%
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Avignon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Obert, Pr.

Role: STUDY_CHAIR

Avignon University

Locations

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Centre Hemodialyse AIDER sante

Nîmes, Gard, France

Site Status

ATIR

Avignon, Vaucluse, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37071035 (View on PubMed)

Other Identifiers

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2020-09-14

Identifier Type: -

Identifier Source: org_study_id