The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients

NCT ID: NCT05718765

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-01-10

Brief Summary

Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795).

The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.

Conditions

Kidney Failure, Chronic; Exercise; Physical Activity; Renal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual care with sham intervention

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

Group Type: SHAM_COMPARATOR

Usual care with sham intervention

Intervention Type: 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 hemodialysis hours.

PACES intervention

PACES includes an exercise perception intervention and an exercise intervention, which lasts for 12 weeks and is carried out simultaneously.

Group Type: EXPERIMENTAL

PACES intervention

Intervention Type: BEHAVIORAL

The exercise perception intervention program is divided into three stage, and every four weeks is a stage. The theme of the first stage is to make the patient have the intention to exercise. The theme of the second stage is to provide effective support for the patient, so that the patient can take the initiative to start exercise. The theme of the third stage is to enable patients to keep exercising.

The exercise intervention is a 12-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours for safety. 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. 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.

Interventions

PACES intervention

The exercise perception intervention program is divided into three stage, and every four weeks is a stage. The theme of the first stage is to make the patient have the intention to exercise. The theme of the second stage is to provide effective support for the patient, so that the patient can take the initiative to start exercise. The theme of the third stage is to enable patients to keep exercising.

The exercise intervention is a 12-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours for safety. 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. 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.

Intervention Type: BEHAVIORAL

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 hemodialysis hours.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adult (age≥18) with stable ESRD;
• receiving≥3 months HD;
• receiving HD more than 5 times every two weeks;
• volunteer for participating in this investigation.

Exclusion Criteria

• are unable to do walk on one's own (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted, walking devices such as cane or walker allowed);
• have shortness of breath at rest or with activities of daily living (NYHA Class IV);
• have mental disease, disturbance of consciousness and couldn't cooperate with this investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Mei Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nursing School of the Air Force Medical University

Xi'an, Shaan XI, China

Countries

China

Other Identifiers

2022SF-077

Identifier Type: -

Identifier Source: org_study_id