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Effects of Intradialytic Exercise on Health-related Quality of Life

Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04990154
Enrollment
64
Registered
2021-08-04
Start date
2019-05-25
Completion date
2020-12-31
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise

Keywords

intradialytic exercise, hemodialysis, health-related quality of life

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.

Detailed description

Exercise has been shown to be of fundamental importance in managing chronic diseases and improving health-related quality of life (HRQL) as well as psychological health. However, whether intradialyic exercise is safe and has positive impact on HRQL and depression status in hemodialysis patients requires further researches with diverse racial and cultural groups to clarify. 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 at a medical center in Northern Taiwan. Sixty-four participants from 112 eligible hemodialysis patients 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 (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week), while the CG maintained usual lifestyles. Dialytic parameters (serum chemistries, serum electrolytes, and estimated glomerular filtration rate), 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 (ß = 22.6, p\<.001) and reduced depression status (ß = -7.5, p = .02) 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.

Interventions

BEHAVIORALa 12-week intradialytic exercise

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

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

outcome assessor was blinded to the group assignment

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* (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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Dialytic parameters: GPT [IU/l]Change from baseline [IU/l] assessed by blood analysis at 12 weeksGPT \[IU/l\]
Dialytic parameters: GOT [IU/l]Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeksGOT \[IU/l\]
Dialytic parameters: red blood cell [count/ul]Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeksred blood cell \[count/ul\]
Dialytic parameters: hemoglobin [g/dl]Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weekshemoglobin \[g/dl\]
Dialytic parameters: hematocrit [%]Change from baseline hematocrit [%] assessed by blood analysis at 12 weekshematocrit \[%\]
Dialytic parameters: mean corpuscular volume [fl]Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeksmean corpuscular volume \[fl\]
Dialytic parameters: albumin [g/dl]Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeksalbumin \[g/dl\]
Dialytic parameters: blood urea nitrogen [BUN, mg/dl]Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeksblood urea nitrogen \[BUN, mg/dl\]
Dialytic parameters: creatinine [Cr, mg/dl])Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weekscreatinine \[Cr, mg/dl\])
Dialytic parameters: sodium [Na, mEq/l]Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weekssodium \[Na, mEq/l\]
Dialytic parameters: potassium [K, mEq/l]Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weekspotassium \[K, mEq/l\]
Dialytic parameters: calcium [Ca, mg/dl]Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weekscalcium \[Ca, mg/dl\]
Dialytic parameters: phosphate [P, mg/dl]Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeksphosphate \[P, mg/dl\]
Dialytic parameters: IPTH [pg/ml]Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeksIPTH \[pg/ml\]
Dialytic parameters: estimated GFR [ml/min1.73m2])Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeksestimated GFR \[ml/min1.73m2\])
health-related quality of life assessed by the scale of SF-36Change from baseline health-related quality of life at 12 weeksself-reported health-related quality of life
depression status assessed by the scale of Beck Depression inventoryChange from baseline depression status at 12 weeksself-reported depression status

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026