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

NCT04124549 | Completed DMC

• 1 other identifier: 2018538
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

End-Stage Renal Disease; Exercise; Dialysis Efficacy; Physical Fitness

Outcome Measures

Primary Outcomes (2)

• Dialysis Efficacy (sp Kt/V)

  Sp Kt/V is a dimensionless, mathematical representation of serum urea clearance, monitored by On-Line Clearance Monitor (OCM)-equipped Fresenius 4008-S machines (Fresenius, Bad Homburg, Germany).

  sp Kt/V was measured at baseline (before intervention) and after 24 weeks of intervention.

• Dialysis Efficacy (sp Kt/V)

  Sp Kt/V is a dimensionless, mathematical representation of serum urea clearance, monitored by On-Line Clearance Monitor (OCM)-equipped Fresenius 4008-S machines (Fresenius, Bad Homburg, Germany).

  sp Kt/V was measured after 4, 8, 12, 16 and 20 weeks of intervention for observing the effects of intervention and time on sp Kt/V more accurately.

Secondary Outcomes (5)

• Blood Pressure (including systolic blood pressure (SBP) and diastolic blood pressure (DBP))

  BP was measured at baseline (before intervention), 12 weeks after intervention and 24 weeks after intervention.

• Six-minute walk test (6MWT)

  6MWT was measured at baseline (before intervention), 12 weeks after intervention and 24 weeks after intervention.

• 5-repetition sit-to-stand test (STS 5)

  The STS-5 was measured at baseline (before intervention), 12 weeks after intervention and 24 weeks after intervention.

• 30-second sit-to-stand test (STS 30)

  The STS-30 was measured at baseline (before intervention), 12 weeks after intervention and 24 weeks after intervention.

• Kidney Disease Quality of Life (KDQOL-36)

  The KDQOL-36TM was measured at baseline (before intervention), 12 weeks after intervention and 24 weeks after intervention.

Study Arms (2)

Stand of Care

SHAM COMPARATOR

Patients in the control group received usual care with sham exercise.

Other: Usual care with sham intervention

Combined Exercise

EXPERIMENTAL

The intervention was a 24-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours. Each exercise lasted about 40 minutes.

Other: Intradialytic Combined Exercise

Interventions

Usual care with sham intervention OTHER

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.

Stand of Care

Intradialytic Combined Exercise OTHER

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.

Combined Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age≥18) with stable ESRD.
• Receiving≥3 months HD.
• HD 3 times per week.
• Volunteer for participating this trial.

You may not qualify if:

• Unable to exercise (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted) (walking device such as cane or walker allowed).
• Had shortness of breath at rest or with activities of daily living (NYHA Class IV).
• Had mental disease, disturbance of consciousness and couldn't cooperate with investigations and exercise.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Aili Lv, Doctor

  Xi'an Jiaotong University Health Science Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in the HD centers were randomly assigned to one of two wards at the time that they began to HD in this center. And in order to avoid contamination, randomization in this study was in accordance with the centers to which patients were assigned. Every HD center was randomized to either continue on usual HD care (control group) or intervention of intradialytic combined exercise based on usual HD care (intervention group).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 11, 2019
• Study Start: March 11, 2019
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)