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Exercise and Vascular Parameters in Hemodialysis

4 aprile 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  1. change in gait speed before and after the exercise program
  2. change in pulse wave velocity before and after the exercise program
  3. change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before and after the exercise program

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 95 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male or female, aged 18-95 years
  2. Able to comply with the study procedures and medication
  3. Written informed consent given
  4. On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
  5. Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program

Exclusion Criteria:

  1. Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
  2. Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
  3. Serum iPTH > 250 pmol/L within 30 days prior to screening visit
  4. 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
  5. Severe peripheral vascular disease
  6. Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks
  7. Current active cancer (excluding basal cell carcinoma of the skin)
  8. Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment
  9. Anticipated live donor kidney transplant or any other planned major surgery over the study duration
  10. History of poor adherence to hemodialysis or medical regimen
  11. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Aerobic Exercise program
Intervention of aerobic exercise
Comportamentale: Aerobic Exercise program
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.
Altro: Control
no aerobic exercise program
Altro: Control
No aerobic exercise is offered but baseline and end of study testing of the outcomes occur

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Gait speed
Lasso di tempo: 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.
at 24 weeks and 48 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Pulse wave velocity (PWV)
Lasso di tempo: 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
at 24 weeks and 48 weeks
Change from Baseline Pulse wave analysis
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
change from baseline micro RNA levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sameena Iqbal

Investigatori

  • Investigatore principale: Sameena Iqbal, McGill University Health Centre/Research Institute of the McGill University Health Centre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2015

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 febbraio 2016

Date di iscrizione allo studio

Primo inviato

19 novembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2016

Primo Inserito (Stima)

2 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 aprile 2017

Ultimo verificato

1 aprile 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 12-309-GEN

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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