Effects of Intradialytic Exercise on Health-related Quality of Life

NCT04990154 | Completed DMC

• 1 other identifier: TSGHIRB: 1-108-05-070
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of intradialyic exercise on dialytic parameters, HRQL, and depression status in hemodialysis patients. A randomized controlled trial was conducted. Sixty-four participants were recruited using stratified random sampling and allocated with a 1:1 randomization ratio to either experimental group (EG, treated in odd weekdays, n = 32) or comparison group (CG, treated in even weekdays, n = 32). The EG received a 12-week intradialytic exercise, while the CG maintained usual lifestyles. Dialytic parameters, HRQL, and depression status were collected at baseline and at 12 weeks. The results indicated that there were no differences in changes of dialytic parameters from baseline between EG and CG. However, the EG had increased HRQL and reduced depression status at 12 weeks compared with the CG. A 12-week intradialytic exercise is safe, feasible and effective in improved HRQL and reduced depression status for hemodialysis patients.

Conditions

Exercise

Keywords

intradialytic exercise; hemodialysis; health-related quality of life

Outcome Measures

Primary Outcomes (17)

• Dialytic parameters: red blood cell [count/ul]

  red blood cell \[count/ul\]

  Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks

• Dialytic parameters: hemoglobin [g/dl]

  hemoglobin \[g/dl\]

  Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks

• Dialytic parameters: hematocrit [%]

  hematocrit \[%\]

  Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks

• Dialytic parameters: mean corpuscular volume [fl]

  mean corpuscular volume \[fl\]

  Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks

• Dialytic parameters: albumin [g/dl]

  albumin \[g/dl\]

  Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks

• Dialytic parameters: GPT [IU/l]

  GPT \[IU/l\]

  Change from baseline [IU/l] assessed by blood analysis at 12 weeks

• Dialytic parameters: GOT [IU/l]

  GOT \[IU/l\]

  Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks

• Dialytic parameters: blood urea nitrogen [BUN, mg/dl]

  blood urea nitrogen \[BUN, mg/dl\]

  Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks

• Dialytic parameters: creatinine [Cr, mg/dl])

  creatinine \[Cr, mg/dl\])

  Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks

• Dialytic parameters: sodium [Na, mEq/l]

  sodium \[Na, mEq/l\]

  Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks

• Dialytic parameters: potassium [K, mEq/l]

  potassium \[K, mEq/l\]

  Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks

• Dialytic parameters: calcium [Ca, mg/dl]

  calcium \[Ca, mg/dl\]

  Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks

• Dialytic parameters: phosphate [P, mg/dl]

  phosphate \[P, mg/dl\]

  Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks

• Dialytic parameters: IPTH [pg/ml]

  IPTH \[pg/ml\]

  Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks

• Dialytic parameters: estimated GFR [ml/min1.73m2])

  estimated GFR \[ml/min1.73m2\])

  Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks

• health-related quality of life assessed by the scale of SF-36

  self-reported health-related quality of life

  Change from baseline health-related quality of life at 12 weeks

• depression status assessed by the scale of Beck Depression inventory

  self-reported depression status

  Change from baseline depression status at 12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)

Behavioral: a 12-week intradialytic exercise

control group

NO INTERVENTION

the control group maintained their usual lifestyles

Interventions

a 12-week intradialytic exercise BEHAVIORAL

a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)

experimental group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) ESRD patients on maintenance of hemodialysis; (2) aged 20 to 80 years; (3) able to speak and understand Mandarin; (4) had received regular treatment with hemodialysis (3 times/ week) for at least 6 months; (5) agreed to be randomized to one of the two groups.

You may not qualify if:

• lower limb disabilities, hospitalized patients, treatment with peritoneal dialysis, received hemodialysis less than 3 times/ week, a history of recent acute myocardial infarction, unstable angina, uncontrolled arrhythmia, acute stroke, hospitalization experience within 6 months, cancer, and diagnosed with mental illness, especially depression.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Chia-Huei Lin

Taipei, Hawaii, 11105, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chia-Huei Lin, PhD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor was blinded to the group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A randomized, controlled trial with a two parallel-group design

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 4, 2021
• Study Start: May 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

TW (1)