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Completed

NCT Number: NCT04697459

Chronic Intradialytic Exercise : a Cardioprotective Role

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

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hemodialyse AIDER sante, Nîmes, Gard, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

acute phase

Other

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

Primary outcomes

  1. Changes in myocardial longitudinal deformations

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

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

  2. Changes in myocardial longitudinal deformations

    Time frame: 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).

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

  3. Changes in myocardial circumferential deformations

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

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

  4. Changes in myocardial circumferential deformations

    Time frame: 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).

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

  5. Changes in left ventricular torsion

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

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

  6. Changes in left ventricular torsion

    Time frame: 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).

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

Secondary outcomes

  1. Changes in arterial rigidity

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

    Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.

  2. Changes in Physical fitness

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

    The six-minute walking test (meters); maximal isometric force (newtons) during a knee-extension test and handgrip test using a dynamometer.

  3. Health-related Quality of life

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

    The 36-Item Short Form Health Survey questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  4. Changes in carotid intimal-media wall thickness

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

    The intimal plus media wall thickness (mm) of the right carotid artery will be measured using high-resolution echography.

Sponsors and collaborators

Lead sponsor

University of Avignon

Other

Registry information

Official study title

Chronic Intradialytic Exercise: a Cardioprotective Role

Acronym: EX-CHRODIAL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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