Clinical trial NCT05718765: The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Official title: The Effect of Physical ACtivity Enhancement Scheme (PACES) on Physical Outcomes in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Exercise
Physical Activity
Renal Dialysis
Keywords: End-Stage Renal Disease
Exercise
Physical Activity
Hemodialysis
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: daily steps (paces)
timeFrame: Change from daily steps at 12 weeks.
measure: The Human Activity Profile (HAP)
timeFrame: Change from HAP 12 weeks.
Secondary outcomes:
measure: Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)
timeFrame: DPEBBS is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Self-efficacy for exercise scale (SEE)
timeFrame: SEE is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Social support Rating Scale (SSRS)
timeFrame: SSRS is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Stage of Change Questionnaire
timeFrame: The questionnaire is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Kidney Disease Quality of Life (KDQOL-36)
timeFrame: KDQOL-36 is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Glomerular filtration rate (GFR)
timeFrame: GFR is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Serum levels of IL-6
timeFrame: Serum levels of IL-6 is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: C-reactive protein (CRP)
timeFrame: CRP is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Serum creatinine
timeFrame: Serum creatinine is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: sit-to-stand tests 10 (STS-10)
timeFrame: STS-10 is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: sit-to-stand tests 60 (STS-60)
timeFrame: STS-60 is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Six-minute walk test (6MWT)
timeFrame: 6MWT is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Ejection fraction
timeFrame: Ejection fraction is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Left ventricular mass index
timeFrame: Left ventricular mass index is measured at baseline (before intervention) and after 12 weeks of intervention.
measure: Left ventricular volume index
timeFrame: Left ventricular volume index is measured at baseline (before intervention) and after 12 weeks of intervention.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Nursing School of the Air Force Medical University
state: Shaan XI
Study officials:
References: