Clinical trial NCT05189795: The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Official title: The Construction and Demonstration of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Dialysis
Exercise
Keywords: hemodialysis
physical activity
barriers
benefits
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This investigation intends to investigate the patients in hemodialysis centers of four hospitals in Xi 'an, and include all patients who meet the inclusion and exclusion criteria.

Brief summary: Hemodialysis (HD) is the most commonly used renal replacement therapy in patients with end-stage renal disease (ESRD). More than 553,000 ESRD patients in China are currently receiving HD, but the long-term survival rate is low and the mortality rate is as high as 18%, which is significantly associated with low physical activity (PA). Low PA could decrease cardiopulmonary and muscle function, limit the ability to perform activities of daily living, and increase risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends PA as cornerstone of ESRD rehabilitation. However, HD patients still live with inactive lifestyle. The investigators' previous study have demonstrated that enhancing PA benefits physical function in HD patients. Therefore, this study intends to establish Physical ACtivity Enhancement Scheme (PACES), that is, to take PACES (measured by pedometers) as the investigation core and motivate patients to PACES.

This study will consists of three distinct parts: 1, 2 and 3. In Part 1, the investigators will conduct research on the PA of HD patients through pedometer and questionnaire, and understand the participants' attitude to PA through a series of questionnaires. In Part 2, the investigators will conduct a semi-structured interview to understand HD patients' attitudes and habits towards PA, as well as recommendations for PACES. In Part 3, the investigators will take the results of Part 1 and 2 as the initial draft of PACES and modify the initial draft through the Delphi method to form the final PACES.

The study aims to develop PACES from the perspective of patients to address the above cognitive factors, making it easier for HD patients to enhance PA.


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: Within 48 hours of admission to hospital.
measure: The Human Activity Profile (HAP)
timeFrame: Within 48 hours of admission to hospital.
measure: Expectations and challenges of PA enhancement in HD patients
timeFrame: 6 months.
Secondary outcomes:
measure: Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)
timeFrame: Within 48 hours of admission to hospital.
measure: Self-efficacy for exercise scale (SEE)
timeFrame: Within 48 hours of admission to hospital.
measure: Social support Rating Scale (SSRS)
timeFrame: Within 48 hours of admission to hospital.
measure: Stage of Change Questionnaire
timeFrame: Within 48 hours of admission to hospital.
measure: Kidney Disease Quality of Life (KDQOL-36)
timeFrame: Within 48 hours of admission to hospital.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Nursing School of the Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Nursing School of the Air Force Medical University
name: Chunping Ni, doctor
role: STUDY_DIRECTOR
References: