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

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03996811
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jun 24, 2019
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. subjective quality of life [3rd month after recruited]

   using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

2. subjective quality of life [6rd month after recruited]

   using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

3. subjective quality of life [12rd month after recruited]

   using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

4. subjective quality of life [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 [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 [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 [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 [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 [3rd month after recruited]

   serum

6. objective cardiovascular health index [6rd month after recruited]

   serum

7. objective cardiovascular health index [12rd month after recruited]

   serum

8. objective cardiovascular health index [24rd month after recruited]

   serum

9. check Physical Functioning [3rd month after recruited]

   6MWT(Six Minute Walk Test)

10. check Physical Functioning [6rd month after recruited]

    6MWT(Six Minute Walk Test)

11. check Physical Functioning [12rd month after recruited]

    6MWT(Six Minute Walk Test)

12. check Physical Functioning [24rd month after recruited]

    6MWT(Six Minute Walk Test)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taipei University of Nursing and Health Sciences	Taipei		Taiwan	112

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT03996811
• Other Study ID Numbers: 2019-06-003A
• First Posted: Jun 25, 2019
• Last Update Posted: Mar 16, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 16, 2021