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Clinical Trials/NCT05189795
NCT05189795
Completed
Not Applicable

The Construction and Demonstration of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients

Health Science Center of Xi'an Jiaotong University1 site in 1 country500 target enrollmentSeptember 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Dialysis
Sponsor
Health Science Center of Xi'an Jiaotong University
Enrollment
500
Locations
1
Primary Endpoint
The Human Activity Profile (HAP)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2021
End Date
February 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Health Science Center of Xi'an Jiaotong University
Responsible Party
Principal Investigator
Principal Investigator

Mei Huang

student

Health Science Center of Xi'an Jiaotong University

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.

Outcomes

Primary Outcomes

The Human Activity Profile (HAP)

Time Frame: Within 48 hours of admission to hospital.

HAP is a questionnaire designed to assess general physical activity. It consists of a list of 94 activities ranked in ascending order of level of energy required to perform each activity. Two scores are available from the HAP: a maximum activity score (MAS), reflective of the most taxing activity a respondent is still perform- ing and an adjusted activity score (AAS), reflective of the respondent's daily activity level. The MAS is the number of the highest ranked activity the respondent is still performing. The AAS is calculated by subtracting from the MAS the number of activities that the respondent has stopped performing that rank below the participants' most metabolically intense activity.

Expectations and challenges of PA enhancement in HD patients

Time Frame: 6 months.

The outcomes are qualitative information acquired from semi-structured interviews.

daily steps (paces)

Time Frame: Within 48 hours of admission to hospital.

OMRON electronic pedometer (HJ-321) records the participants' daily steps. Participants are instructed to wear the pedometer on their waist for 7 days, and the pedometer is removed only during rest, bathing and swimming.

Secondary Outcomes

  • Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)(Within 48 hours of admission to hospital.)
  • Self-efficacy for exercise scale (SEE)(Within 48 hours of admission to hospital.)
  • Social support Rating Scale (SSRS)(Within 48 hours of admission to hospital.)
  • Stage of Change Questionnaire(Within 48 hours of admission to hospital.)
  • Kidney Disease Quality of Life (KDQOL-36)(Within 48 hours of admission to hospital.)

Study Sites (1)

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