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

Health Science Center of Xi'an Jiaotong University

Status: Completed

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

Treatments: Other: Usual care with sham intervention; Behavioral: PACES intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05718765

2022SF-077

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Usual care with sham intervention

Sham Comparator group

Description:

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

Treatment:

Other: Usual care with sham intervention

PACES intervention

Experimental group

Description:

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

Treatment:

Behavioral: PACES intervention