Exercise and Vascular Parameters in Hemodialysis
4 avril 2017 mis à jour par: Sameena Iqbal
Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Arterial calcification is very common in the incident hemodialysis population, ranging 71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis population, medial arterial calcification may contribute through increased risk of sudden death and congestive heart failure.
Applanation tonometry is the method of choice to measure pulse wave velocity and pulse wave analysis.
The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter.
The secondary objectives will assess the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The investigators propose a pilot project to assess the effect of a 16 week aerobic exercise program on arterial stiffness and cardiovascular risk in the hemodialysis population. The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter. The secondary objectives will assess the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
Study Design:
Randomized-controlled study of end stage renal disease patients between the age of 18 and 90 years to assess the effect of exercise on arterial stiffness. Our aim is to have 23 patients in both groups. The study period will be 24 weeks-4 weeks for recruitment, 16 weeks for the intervention and 4 weeks for data collection and analysis. The protocol will be submitted to the MUHC Research Ethics Board.
The following outcomes are of interest:
- change in gait speed before and after the exercise program
- change in pulse wave velocity before and after the exercise program
- change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before and after the exercise program
Type d'étude
Interventionnel
Inscription (Réel)
21
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital
-
Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 95 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male or female, aged 18-95 years
- Able to comply with the study procedures and medication
- Written informed consent given
- On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
- Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program
Exclusion Criteria:
- Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
- Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
- Serum iPTH > 250 pmol/L within 30 days prior to screening visit
- Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to recruitment
- Severe peripheral vascular disease
- Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks
- Current active cancer (excluding basal cell carcinoma of the skin)
- Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment
- Anticipated live donor kidney transplant or any other planned major surgery over the study duration
- History of poor adherence to hemodialysis or medical regimen
- Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Aerobic Exercise program
Intervention of aerobic exercise
|
The 16-week program will consist of aerobic-type steady-state or interval exercises using a pedals attachable to the dialysis chairs.
The purpose will be to slowly increase exercise duration by 5 minute increments to reach the goal of 30 min/treatment.
The exercise program during hemodialysis sessions will contain a combination of aerobic and flexibility exercises, about 30 minutes of cycling with 10 minutes of warm up/stretching exercises and 10-15 minutes cool down.
The frequency of exercise will be three sessions a week, during the first hour of dialysis treatment for the duration of 16 weeks.
Blood pressure and heart continuous monitoring will be carried out during the exercise program.
Exercise log sheets will be filled for each session for the 16 weeks.
|
|
Autre: Control
no aerobic exercise program
|
No aerobic exercise is offered but baseline and end of study testing of the outcomes occur
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Gait speed
Délai: at 24 weeks and 48 weeks
|
The gait speed will be measured with a timer (in seconds) as the subject will be asked to walk a 10 foot or 3 meter course and back as quickly as possible.
Two readings will be taken and the average will be recorded.
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at 24 weeks and 48 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline Pulse wave velocity (PWV)
Délai: at 24 weeks and 48 weeks
|
PWV measurements will be performed between the carotid and femoral artery sites, to primarily measure the stiffness of the aorta.
A 3-lead ECG will be used in conjunction with a tonometer to measure the pressure pulse waveform sequentially in the two peripheral artery sites
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at 24 weeks and 48 weeks
|
|
Change from Baseline Pulse wave analysis
Délai: at 24 and 48 weeks
|
Wave Reflections and Arterial Stiffness.
Analysis of the systolic part of the central pressure waveform will be performed to evaluate PWV and the LV afterload.
The main indices that were described above (in hemodynamic measurements) will be obtained by aortic PWA.
|
at 24 and 48 weeks
|
|
Change from baseline Rand survey
Délai: at 24 weeks and 48 weeks
|
RAND 36-item survey will be used to assess physical functioning and fatigue.
This survey has been validated in the Hemodialysis population.
The survey consists of 36 items and takes approximately 5-10 minutes to complete.
|
at 24 weeks and 48 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
change from baseline micro RNA levels
Délai: at 24 weeks and 48 weeks
|
micro RNAs (21, 126, 133, 146a, 221/222 and 210): blood sample will be taken before initiation of dialysis week of baseline measurements and end of study.
|
at 24 weeks and 48 weeks
|
|
change from baseline Brain Natuiretic Peptide
Délai: at 24 weeks and 48 weeks
|
Brain Natuiretic Peptide: measure before initiation of dialysis at baseline and at the end of study period.
|
at 24 weeks and 48 weeks
|
|
change from baseline troponin levels
Délai: at 24 weeks and 48 weeks
|
to assess myocardial injury during dialysis at baseline and at the end of the study
|
at 24 weeks and 48 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Sameena Iqbal, McGill University Health Centre/Research Institute of the McGill University Health Centre
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2015
Achèvement primaire (Réel)
1 novembre 2015
Achèvement de l'étude (Réel)
1 février 2016
Dates d'inscription aux études
Première soumission
19 novembre 2012
Première soumission répondant aux critères de contrôle qualité
29 avril 2016
Première publication (Estimation)
2 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 avril 2017
Dernière vérification
1 avril 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-309-GEN
Plan pour les données individuelles des participants (IPD)
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NON
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