Clinical trial NCT04990154: Effects of Intradialytic Exercise on Health-related Quality of Life
Official title: Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: intradialytic exercise
hemodialysis
health-related quality of life
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled trial with a two parallel-group design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dialytic parameters: red blood cell [count/ul]
timeFrame: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: hemoglobin [g/dl]
timeFrame: Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: hematocrit [%]
timeFrame: Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: mean corpuscular volume [fl]
timeFrame: Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: albumin [g/dl]
timeFrame: Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: GPT [IU/l]
timeFrame: Change from baseline [IU/l] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: GOT [IU/l]
timeFrame: Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: blood urea nitrogen [BUN, mg/dl]
timeFrame: Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: creatinine [Cr, mg/dl])
timeFrame: Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
measure: Dialytic parameters: sodium [Na, mEq/l]
timeFrame: Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: potassium [K, mEq/l]
timeFrame: Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: calcium [Ca, mg/dl]
timeFrame: Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: phosphate [P, mg/dl]
timeFrame: Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: IPTH [pg/ml]
timeFrame: Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks
measure: Dialytic parameters: estimated GFR [ml/min1.73m2])
timeFrame: Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks
measure: health-related quality of life assessed by the scale of SF-36
timeFrame: Change from baseline health-related quality of life at 12 weeks
measure: depression status assessed by the scale of Beck Depression inventory
timeFrame: Change from baseline depression status at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Huei Lin
state: Hawaii
Study officials:
affiliation: Tri-Service General Hospital
name: Chia-Huei Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: