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

NCT ID: NCT05189795

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-06

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Dialysis Exercise

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Mei Huang

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunping Ni, doctor

Role: STUDY_DIRECTOR

Nursing School of the Air Force Medical University

Locations

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Nursing School of the Air Force Medical University

Xi'an, Shaan'xi, China

Site Status

Countries

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China

References

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Huang M, Lv A, Yang F, Tang Y, Li Y, Hua Y, Gao J, Ni C. Impacts of cognition of exercise on physical activity participation in hemodialysis patients. Semin Dial. 2023 Sep-Oct;36(5):366-373. doi: 10.1111/sdi.13138. Epub 2023 Jan 3.

Reference Type DERIVED
PMID: 36597274 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2021SF-278

Identifier Type: -

Identifier Source: org_study_id

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