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

NCT05718765 | Completed

• 1 other identifier: 2022SF-077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795). The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.

Conditions

Kidney Failure, Chronic; Exercise; Physical Activity; Renal Dialysis

Keywords

End-Stage Renal Disease; Exercise; Physical Activity; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from daily steps at 12 weeks.

• 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 performing 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. The minimum and maximum values of MAS and AAS are 0 and 94 respectively. The higher the score, the stronger the physical activity of the patient.

  Change from HAP 12 weeks.

Secondary Outcomes (15)

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

  DPEBBS is measured at baseline (before intervention) and after 12 weeks of intervention.

• Self-efficacy for exercise scale (SEE)

  SEE is measured at baseline (before intervention) and after 12 weeks of intervention.

• Social support Rating Scale (SSRS)

  SSRS is measured at baseline (before intervention) and after 12 weeks of intervention.

• Stage of Change Questionnaire

  The questionnaire is measured at baseline (before intervention) and after 12 weeks of intervention.

• Kidney Disease Quality of Life (KDQOL-36)

  KDQOL-36 is measured at baseline (before intervention) and after 12 weeks of intervention.

Study Arms (2)

Usual care with sham intervention

SHAM COMPARATOR

Patients in the control group received usual care with sham exercise.

Other: Usual care with sham intervention

PACES intervention

EXPERIMENTAL

PACES includes an exercise perception intervention and an exercise intervention, which lasts for 12 weeks and is carried out simultaneously.

Behavioral: PACES intervention

Interventions

PACES intervention BEHAVIORAL

The exercise perception intervention program is divided into three stage, and every four weeks is a stage. The theme of the first stage is to make the patient have the intention to exercise. The theme of the second stage is to provide effective support for the patient, so that the patient can take the initiative to start exercise. The theme of the third stage is to enable patients to keep exercising. The exercise intervention is a 12-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours for safety. Each session consisted of a 5-minute warm-up, cool-down and 30-minute cycling at a Rating of Perceived Exertion (RPE) of 12-14. The machine has two exercise types including aerobic exercise and resistance exercise. Every four weeks is divided into a stage. And the time of aerobic exercise and resistance exercise were personally adjusted per stage to maintain the personalized target RPE.

PACES intervention

Usual care with sham intervention OTHER

Patients in the control group received usual care and were advised to do sham exercise such as stretch legs and arms about 15 minutes during the first 2 hemodialysis hours.

Usual care with sham intervention

Eligibility Criteria

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

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, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: February 8, 2023
• Study Start: September 20, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

CN (1)