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

NCT05189795 | Completed

• 1 other identifier: 2021SF-278
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis; Exercise

Keywords

hemodialysis; physical activity; barriers; benefits

Outcome Measures

Primary Outcomes (3)

• daily steps (paces)

  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.

  Within 48 hours of admission to hospital.

• The Human Activity Profile (HAP)

  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.

  Within 48 hours of admission to hospital.

• Expectations and challenges of PA enhancement in HD patients

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

  6 months.

Secondary Outcomes (5)

• 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

Nursing School of the Air Force Medical University

Xi'an, Shaan'xi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 36597274 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chunping Ni, doctor

  Nursing School of the Air Force Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: January 13, 2022
• Study Start: September 6, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)