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Exercise and Vascular Parameters in Hemodialysis

4. april 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 95 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Aerobic Exercise program
Intervention of aerobic exercise
Atferdsmessig: 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.
Annen: Control
no aerobic exercise program
Annen: Control
No aerobic exercise is offered but baseline and end of study testing of the outcomes occur

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Gait speed
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Pulse wave velocity (PWV)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change from baseline micro RNA levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sameena Iqbal

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2015

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først innsendt

19. november 2012

Først innsendt som oppfylte QC-kriteriene

29. april 2016

Først lagt ut (Anslag)

2. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. april 2017

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 12-309-GEN

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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