Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months.
详细描述
The investigators incorporated patient-provider preferences of the key stakeholders, and used a multi-disciplinary team with experts in physical therapy, psychology and nephrology to develop a comprehensive exercise program for HD patients. Aim of this pilot study is to assess the feasibility, tolerability and adherence to COMEX over 3 months and inform design of future randomized controlled trial. A secondary goal is to explore molecular mechanisms in muscle and blood of exercise adaptation in HD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients:
- •Age ≥18 years to 85 years
- •Undergoing maintenance hemodialysis for >3 months at one of the participating dialysis sites
- •Patients must be willing and able to sign the consent form.
- •For providers:
- •Eligible if they are a registered nurse, dialysis technician, dialysis social worker, dietitian, dialysis unit administrator or nephrologist involved in providing care for one of the patient participants in the study
排除标准
- •For all patients:
- •Uncontrolled BP (>180/100 mm Hg)
- •Inadequately dialyzed (Kt/V<1.2)
- •History of Intradialytic hypotension (SBP<90mm Hg) or hypertension (SBP>180mmHg) during/post dialysis within last 1 month
- •Contraindication to exercise eg unstable angina, uncompensated congestive heart failure
- •Refractory/untreated psychiatric disorders
- •History of poor adherence to HD treatment.
- •Scheduled for living donor kidney transplant, intention to change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 6 months.
- •Currently in acute or chronic care hospital
- •Life expectancy < 6 months or intention to withdraw dialysis therapy within 6 months.
- •Current pregnancy, or actively planning to become pregnant in the next 6 months
- •Currently a prisoner
- •Current use of investigational drugs or participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
- •Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
- •Unable or unwilling to provide informed consent or sign IRB-approved consent form
- •Has a tunneled dialysis catheter
- •If diabetic, blood sugar control is not stable
- •For patients undergoing biopsy and blood draw:
- •Allergy to lidocaine
- •Anemia, <10.0 Hgb
- •Chronic use of oral corticosteroids or other medication that affect muscle function
- •Any bleeding disorder that would contraindicate biopsy or blood draw such as a history of clinically significant bleeding diathesis (e.g. hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency)
研究组 & 干预措施
COMEX
Patients receive comprehensive exercise intervention
干预措施: COMEX intervention (Other)
结局指标
主要结局
Recruitment rate
时间窗: 3 months
Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.
Number of participants with exercise-related adverse events
时间窗: 3 months
Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records
Adherence rate
时间窗: 3 months
Adherence will be calculated as % of participants who complete the 3 month COMEX intervention. Also, adherence to exercise will be calculated as % of exercise sessions completed
次要结局
- Sleep/Wake Behavior by Actigraphy(3 months)
- Sleep(3 months)
- Fatigue(3 months)
- Depression(3 months)
- Global health(3 months)
- Health related quality of life(3 months)
- Physical functioning(3 months)
研究者
Manisha Jhamb
MD
University of Pittsburgh