The Effect of Intradialytic Combined Exercise on Physical Outcomes in End-Stage Renal Disease Patients

NCT04124549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-11-26

No results posted yet for this study

Summary

Hemodialysis (HD) is an important and commonly used renal replacement therapy (RRT) for End-Stage Renal Disease (ESRD) patients worldwide. Inadequate HD, impaired exercise capacity and declined peripheral muscular strength resulted by HD and ESRD are still disturbing problems, which also predicts poor renal prognosis and poor quality of life. The results of systematic reviews by the investigators have shown that aerobic exercise and combined exercise can improve dialysis efficacy (alleviate uremia symptoms), improve aerobic exercise capacity and muscle strength, and improve patients' quality of life, which also supports the notion that the National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends exercise as cornerstone of ESRD rehabilitation. Therefore, this study used the effective exercise type of the systematic review results - combined exercise as an intervention method to observe its effects on dialysis efficacy, blood pressure, aerobic exercise capacity, muscle strength and quality of life.

The study hypothesized that combined exercise can not only improve dialysis efficacy, but also has an interaction effect with intervention duration, which deserves researches' attention. Combined exercise will also improve blood pressure (including systolic blood pressure and diastolic blood pressure) in patients with ESRD and reduce the symptoms of renal hypertension. It will also improve the exercise capacity and muscle strength of ESRD patients and improve their quality of life.

Conditions

  • Kidney Failure, Chronic
  • Exercise
  • Physical Fitness

Interventions

OTHER

Usual care with sham intervention

Patients in the control group received usual care and were advised to do sham exercise such as stretch legs and arms about 15 minutes during the first 2 HD hours.

OTHER

Intradialytic Combined Exercise

Each session consisted of a 5-minute warm-up, cool-down and 30-minute cycling at a Rating of Perceived Exertion (RPE) of 12-14. The machine has two exercise types including aerobic exercise and resistance exercise. Patients were asked to perform aerobic exercise 20-min and resistance exercise 10-min in the first stage. Every four weeks is divided into a stage. And the time of aerobic exercise and resistance exercise were personally adjusted per stage to maintain the personalized target RPE. In the following stages, aerobic exercise was continued 15-min for the second stage, 10-min for the third and the forth stage, 15-min for the fifth stage and 20-min for the last stage. And the time for resistance exercise was adjusted for the total exercise time. The resistance of exercise also progressive increased in order to adapt the target RPE. It was accessible to patients of different ages, gender, cultures and ethnicities.

Sponsors & Collaborators

  • Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Aili Lv, Doctor · Xi'an Jiaotong University Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04124549 on ClinicalTrials.gov