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Renal DialysisNCT05189795

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

An observational study of Renal Dialysis and Exercise, run by Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Renal Dialysis, Exercise
How many people
500 participants
Where
1 siteChina
Study dates
6 Sep 2021to 1 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nursing School of the Air Force Medical University

    Xi'an, Shaan'xi, 710032

Other trials in China

About this study

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

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.

Keywords
hemodialysis, physical activity, barriers, benefits
Medical subject headings
Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 48 hours of admission to hospital.

  2. 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.

    Measured: Within 48 hours of admission to hospital.

  3. Expectations and challenges of PA enhancement in HD patients

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

    Measured: 6 months.

Secondary outcomes (5)

  1. Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)

    The 24-item DPEBBS is used to evaluate participants' perceived benefits and barriers to exercise. The scale consisted of 24 items and 2 open questions, including 12 items of exercise benefits and 12 items of exercise barriers. Total scores ranged from 24 to 96. The higher the score, the more exercise benefits the patients experienced and the fewer factors that prevented them from exercise.

    Measured: Within 48 hours of admission to hospital.

  2. Self-efficacy for exercise scale (SEE)

    SEE is used to identify the participants' confidence in their ability to exercise, which is a major determinant in the success of changing behavior. The score ranges from 0 to 100, and the higher the score, the higher the level of self-efficacy.

    Measured: Within 48 hours of admission to hospital.

  3. Social support Rating Scale (SSRS)

    Participants' social support status is measured by the SSRS. The scale has 10 items, including 3 aspects, objective support, subjective support and utilization of social support. The total score is the sum of points for each item. The higher the score is, the higher the degree of social support is. The scale scores range from 12 to 66, with ≤22 being low, 23 to 44 medium, and 45 to 66 high.

    Measured: Within 48 hours of admission to hospital.

  4. Stage of Change Questionnaire

    The questionnaire identifies the participants' state of readiness to adopt a more active lifestyle according to the Health Action Process Approach.

    Measured: Within 48 hours of admission to hospital.

  5. Kidney Disease Quality of Life (KDQOL-36)

    KDQOL-36, consisted of the 12-item Short Form Health Survey (SF-12) including the physical component summary (PCS) and the mental component summary (MCS) and 24 disease-specific items which entail 3 subscales: the symptom and problems list, the burden of kidney disease, and the effects of kidney disease, is to evaluate patients' QoL. Scores of each dimension range from 0 to 100 and higher scores represent better QoL.

    Measured: Within 48 hours of admission to hospital.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2022
  2. Study start6 Sep 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05189795
Sponsor's protocol ID
2021SF-278
Status last verified
Mar 2022
First submitted
27 Nov 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36597274

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Dialysis and Exercise, run by Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

daily steps (paces) (time frame: Within 48 hours of admission to hospital.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05189795, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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Clinical Trial NCT05189795 | AzTrials