HemodialysisNCT03996811
The Effectiveness of Home-based Walking Program in Improving Quality of Life in Patients With Hemodialysis
A study testing Exercise education in people with Hemodialysis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study will investigate the effectiveness of a rehabilitation program in improving physical functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan. Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Exercise education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2019to 31 Jul 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients with hemodialysis who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, 6-minute walking test ≧ 300m and not cognitively impaired were included.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei, 112
Hui-Mei Chen, PhD, 886-939654302, alice@ntunhs.edu.tw
About this study
Official title: The Effectiveness of Home-based Walking Program in Improving Physical Functioning, Cardiovascular Health Index, Negative Emotions, and Quality of Life in Patients With Hemodialysis
This study will investigate the effectiveness of a rehabilitation program in improving physical functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan.
Hypothesis:
- The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The negative emotions in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The cardiovascular health index in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The Physical Functioning in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
Read the detailed description
This study will investigate the effectiveness of a rehabilitation program in improving Physical Functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan.
- Conditions
- Hemodialysis
- Being tested
- Exercise education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise educationOther
weekly telephone consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | exercise education: A 12-week regimen of home-based walking exercises, include moderate intensity for 40 min, three times a week on non-dialysis days. We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the target heart rate, as determined by the Karvonen method, and 12-13 on the RPE. Receives: Other: Exercise education |
| usual-care group | No intervention | Hospital routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective quality of life
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
Measured: 3rd month after recruited
subjective quality of life
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
Measured: 6rd month after recruited
subjective quality of life
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
Measured: 12rd month after recruited
subjective quality of life
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
Measured: 24rd month after recruited
Secondary outcomes (12)
subjective negative emotions
negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Measured: 3rd month after recruited
subjective negative emotions
negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Measured: 6rd month after recruited
subjective negative emotions
negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Measured: 12rd month after recruited
subjective negative emotions
negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Measured: 24rd month after recruited
objective cardiovascular health index
serum
Measured: 3rd month after recruited
objective cardiovascular health index
serum
Measured: 6rd month after recruited
objective cardiovascular health index
serum
Measured: 12rd month after recruited
objective cardiovascular health index
serum
Measured: 24rd month after recruited
check Physical Functioning
6MWT(Six Minute Walk Test)
Measured: 3rd month after recruited
check Physical Functioning
6MWT(Six Minute Walk Test)
Measured: 6rd month after recruited
check Physical Functioning
6MWT(Six Minute Walk Test)
Measured: 12rd month after recruited
check Physical Functioning
6MWT(Six Minute Walk Test)
Measured: 24rd month after recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start24 Jun 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, PhD, Principal investigator, National Taipei University of Nursing and Health SciencesHsin-Ling Tai, Master, Principal investigator, Taipei Veterans General Hospital, TaiwanJiu-Yun Tian, University, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996811
- Sponsor's protocol ID
- 2019-06-003A
- Status last verified
- Mar 2021
- First submitted
- 23 Jun 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Home-based Walking Program in Improving Physical Functioning, Cardiovascular Health Index, Negative Emotions, and Quality of Life in Patients With Hemodialysis
- ClinicalTrials.gov ID
- NCT03996811
- Acronym / sponsor ID
- 2019-06-003A
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 Jun 2019 (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 will investigate the effectiveness of a rehabilitation program in improving physical functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan.
Hypothesis:
- The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The negative emotions in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The cardiovascular health index in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
- The Physical Functioning in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
Detailed description
This study will investigate the effectiveness of a rehabilitation program in improving Physical Functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Exercise educationexercise education: A 12-week regimen of home-based walking exercises, include moderate intensity for 40 min, three times a week on non-dialysis days. We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the target heart rate, as determined by the Karvonen method, and 12-13 on the RPE. |
| usual-care group | No intervention | –Hospital routine care |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with hemodialysis who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, 6-minute walking test ≧ 300m and not cognitively impaired were included.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Exercise educationweekly telephone consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects. | Other | exercise group |
Primary outcome
subjective quality of life
Time frame: 3rd month after recruited
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
subjective quality of life
Time frame: 6rd month after recruited
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
subjective quality of life
Time frame: 12rd month after recruited
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
subjective quality of life
Time frame: 24rd month after recruited
using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.
12 secondary outcomes
subjective negative emotions
Time frame: 3rd month after recruited
subjective negative emotions
Time frame: 6rd month after recruited
subjective negative emotions
Time frame: 12rd month after recruited
subjective negative emotions
Time frame: 24rd month after recruited
objective cardiovascular health index
Time frame: 3rd month after recruited
objective cardiovascular health index
Time frame: 6rd month after recruited
objective cardiovascular health index
Time frame: 12rd month after recruited
objective cardiovascular health index
Time frame: 24rd month after recruited
check Physical Functioning
Time frame: 3rd month after recruited
check Physical Functioning
Time frame: 6rd month after recruited
check Physical Functioning
Time frame: 12rd month after recruited
check Physical Functioning
Time frame: 24rd month after recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Hui-Mei Chen, PhD principal investigator
National Taipei University of Nursing and Health Sciences
Hsin-Ling Tai, Master principal investigator
Taipei Veterans General Hospital, Taiwan
Jiu-Yun Tian, University study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise education in people with Hemodialysis, run by Taipei Veterans General Hospital, Taiwan 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: status not confirmed, as of the sponsor's last update on 16 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Mei Chen, PhD (886-939654302, alice@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective quality of life (time frame: 3rd month after recruited). The study lists 4 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 16 Mar 2021.