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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Home-based Walking Program in Improving Physical Functioning, Cardiovascular Health Index, Negative Emotions, and Quality of Life in Patients With Hemodialysis

Conditions
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Hemodialysis

Intervention / Treatment
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* Other: Exercise education


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise group<br>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<br>* 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.<br>|
| No Intervention: usual-care group<br>Hospital routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective quality of life | using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life. | 3rd month after recruited | 
| subjective quality of life | using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life. | 6rd month after recruited | 
| subjective quality of life | using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life. | 12rd month after recruited | 
| subjective quality of life | using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life. | 24rd month after recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 24rd month after recruited | 
| objective cardiovascular health index | serum | 3rd month after recruited | 
| objective cardiovascular health index | serum | 6rd month after recruited | 
| objective cardiovascular health index | serum | 12rd month after recruited | 
| objective cardiovascular health index | serum | 24rd month after recruited | 
| check Physical Functioning | 6MWT(Six Minute Walk Test) | 3rd month after recruited | 
| check Physical Functioning | 6MWT(Six Minute Walk Test) | 6rd month after recruited | 
| check Physical Functioning | 6MWT(Six Minute Walk Test) | 12rd month after recruited | 
| check Physical Functioning | 6MWT(Six Minute Walk Test) | 24rd month after recruited |