Exercise and Vascular Parameters in Hemodialysis
2017년 4월 4일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
중재적
등록 (실제)
21
단계
- 해당 없음
연락처 및 위치
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연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H3A 1A1
- Royal Victoria Hospital
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Montreal, Quebec, 캐나다, H3G 1A4
- Montreal General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Aerobic Exercise program
Intervention of aerobic exercise
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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.
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다른: Control
no aerobic exercise program
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No aerobic exercise is offered but baseline and end of study testing of the outcomes occur
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Gait speed
기간: at 24 weeks and 48 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline Pulse wave velocity (PWV)
기간: at 24 weeks and 48 weeks
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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
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Change from Baseline Pulse wave analysis
기간: at 24 and 48 weeks
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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.
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at 24 and 48 weeks
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Change from baseline Rand survey
기간: at 24 weeks and 48 weeks
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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.
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at 24 weeks and 48 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change from baseline micro RNA levels
기간: at 24 weeks and 48 weeks
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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.
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at 24 weeks and 48 weeks
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change from baseline Brain Natuiretic Peptide
기간: at 24 weeks and 48 weeks
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Brain Natuiretic Peptide: measure before initiation of dialysis at baseline and at the end of study period.
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at 24 weeks and 48 weeks
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change from baseline troponin levels
기간: at 24 weeks and 48 weeks
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to assess myocardial injury during dialysis at baseline and at the end of the study
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at 24 weeks and 48 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Sameena Iqbal, McGill University Health Centre/Research Institute of the McGill University Health Centre
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 2월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2016년 2월 1일
연구 등록 날짜
최초 제출
2012년 11월 19일
QC 기준을 충족하는 최초 제출
2016년 4월 29일
처음 게시됨 (추정)
2016년 5월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 4일
마지막으로 확인됨
2016년 4월 1일
추가 정보
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