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The Effectiveness of Home-based Walking Program in Improving Quality of Life in Patients With Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996811
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief 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. The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  2. The negative emotions in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  3. The cardiovascular health index in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  4. The Physical Functioning in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.

Condition or disease Intervention/treatment Phase
Hemodialysis Other: Exercise education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise group
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.
Other: Exercise education
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.

No Intervention: usual-care group
Hospital routine care



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. subjective negative emotions [ Time Frame: 3rd month after recruited ]
    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.

  2. subjective negative emotions [ Time Frame: 6rd month after recruited ]
    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.

  3. subjective negative emotions [ Time Frame: 12rd month after recruited ]
    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.

  4. subjective negative emotions [ Time Frame: 24rd month after recruited ]
    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.

  5. objective cardiovascular health index [ Time Frame: 3rd month after recruited ]
    serum

  6. objective cardiovascular health index [ Time Frame: 6rd month after recruited ]
    serum

  7. objective cardiovascular health index [ Time Frame: 12rd month after recruited ]
    serum

  8. objective cardiovascular health index [ Time Frame: 24rd month after recruited ]
    serum

  9. check Physical Functioning [ Time Frame: 3rd month after recruited ]
    6MWT(Six Minute Walk Test)

  10. check Physical Functioning [ Time Frame: 6rd month after recruited ]
    6MWT(Six Minute Walk Test)

  11. check Physical Functioning [ Time Frame: 12rd month after recruited ]
    6MWT(Six Minute Walk Test)

  12. check Physical Functioning [ Time Frame: 24rd month after recruited ]
    6MWT(Six Minute Walk Test)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996811


Contacts
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Contact: Hui-Mei Chen, PhD 886-939654302 alice@ntunhs.edu.tw
Contact: Hsin-Ling Tai, Master 886-937546170 hltai@vghtpe.gov.tw

Locations
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Taiwan
National Taipei University of Nursing and Health Sciences Recruiting
Taipei, Taiwan, 112
Contact: Hui-Mei Chen, PhD    886-939654302    alice@ntunhs.edu.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Hui-Mei Chen, PhD National Taipei University of Nursing and Health Sciences
Principal Investigator: Hsin-Ling Tai, Master Taipei Veterans General Hospital, Taiwan
Study Director: Jiu-Yun Tian, University Taipei Veterans General Hospital, Taiwan
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03996811    
Other Study ID Numbers: 2019-06-003A
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No