ExerciseNCT04990154
Effects of Intradialytic Exercise on Health-related Quality of Life
A study testing a 12-week intradialytic exercise in people with Exercise, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Exercise
- What is being tested?
- a 12-week intradialytic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2019to 31 Dec 2020
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Exercise
- Being tested
- a 12-week intradialytic exercise
- Keywords
- intradialytic exercise, hemodialysis, health-related quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a 12-week intradialytic exerciseBehavioural
a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week) Receives: Behavioral: a 12-week intradialytic exercise |
| control group | No intervention | the control group maintained their usual lifestyles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialytic parameters: red blood cell [count/ul]
red blood cell [count/ul]
Measured: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
Dialytic parameters: hemoglobin [g/dl]
hemoglobin [g/dl]
Measured: Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: hematocrit [%]
hematocrit [%]
Measured: Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
Dialytic parameters: mean corpuscular volume [fl]
mean corpuscular volume [fl]
Measured: Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
Dialytic parameters: albumin [g/dl]
albumin [g/dl]
Measured: Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: GPT [IU/l]
GPT [IU/l]
Measured: Change from baseline [IU/l] assessed by blood analysis at 12 weeks
Dialytic parameters: GOT [IU/l]
GOT [IU/l]
Measured: 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]
Measured: 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])
Measured: Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
Dialytic parameters: sodium [Na, mEq/l]
sodium [Na, mEq/l]
Measured: Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
Dialytic parameters: potassium [K, mEq/l]
potassium [K, mEq/l]
Measured: Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
Dialytic parameters: calcium [Ca, mg/dl]
calcium [Ca, mg/dl]
Measured: Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: phosphate [P, mg/dl]
phosphate [P, mg/dl]
Measured: Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: IPTH [pg/ml]
IPTH [pg/ml]
Measured: 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])
Measured: 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
Measured: 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
Measured: Change from baseline depression status at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start25 May 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled trial with a two parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIA-HUEI LIN, PhD, Tri-Service General Hospital (TSGH)
- Investigators
- Chia-Huei Lin, PhD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990154
- Sponsor's protocol ID
- TSGHIRB: 1-108-05-070
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04990154
- Acronym / sponsor ID
- TSGHIRB: 1-108-05-070
- Conditions
- Exercise
- Keywords
- intradialytic exercise, hemodialysis, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled trial with a two parallel-group design
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: a 12-week intradialytic exerciseThe experimental group received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week) |
| control group | No intervention | –the control group maintained their usual lifestyles |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a 12-week intradialytic exercisea 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week) | Behavioural | experimental group |
Primary outcome
Dialytic parameters: red blood cell [count/ul]
Time frame: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
red blood cell [count/ul]
Dialytic parameters: hemoglobin [g/dl]
Time frame: Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
hemoglobin [g/dl]
Dialytic parameters: hematocrit [%]
Time frame: Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
hematocrit [%]
Dialytic parameters: mean corpuscular volume [fl]
Time frame: Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
mean corpuscular volume [fl]
Dialytic parameters: albumin [g/dl]
Time frame: Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
albumin [g/dl]
Dialytic parameters: GPT [IU/l]
Time frame: Change from baseline [IU/l] assessed by blood analysis at 12 weeks
GPT [IU/l]
Dialytic parameters: GOT [IU/l]
Time frame: Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks
GOT [IU/l]
Dialytic parameters: blood urea nitrogen [BUN, mg/dl]
Time frame: Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks
blood urea nitrogen [BUN, mg/dl]
Dialytic parameters: creatinine [Cr, mg/dl])
Time frame: Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
creatinine [Cr, mg/dl])
Dialytic parameters: sodium [Na, mEq/l]
Time frame: Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
sodium [Na, mEq/l]
Dialytic parameters: potassium [K, mEq/l]
Time frame: Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
potassium [K, mEq/l]
Dialytic parameters: calcium [Ca, mg/dl]
Time frame: Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
calcium [Ca, mg/dl]
Dialytic parameters: phosphate [P, mg/dl]
Time frame: Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
phosphate [P, mg/dl]
Dialytic parameters: IPTH [pg/ml]
Time frame: Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks
IPTH [pg/ml]
Dialytic parameters: estimated GFR [ml/min1.73m2])
Time frame: Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks
estimated GFR [ml/min1.73m2])
health-related quality of life assessed by the scale of SF-36
Time frame: Change from baseline health-related quality of life at 12 weeks
self-reported health-related quality of life
depression status assessed by the scale of Beck Depression inventory
Time frame: Change from baseline depression status at 12 weeks
self-reported depression status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Huei Lin, PhD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a 12-week intradialytic exercise in people with Exercise, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 1 inclusion and 1 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 4 Aug 2021. 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 Taiwan. 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?
Dialytic parameters: red blood cell [count/ul] (time frame: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.