Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome
Primary Purpose
Sleep Apnea Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
stair stepping exercise
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Apnea Syndrome focused on measuring Stair stepping training, OSAS, cardiopulmonary fitness, sleep disturbance, Actigraphy
Eligibility Criteria
Inclusion Criteria:
- being diagnosed with AHI (Apnea-hypopnea index)>15/hr and ODI (oxygen desaturation index)>10/hr by Polysomnography
- aged 19 or older
Exclusion Criteria:
- unstable angina
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00952172
First Posted
August 3, 2009
Last Updated
August 4, 2009
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00952172
Brief Title
Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome
Official Title
Effectiveness of Stair Stepping Exercise Training on Cardiopulmonary Fitness and Sleep Situation in Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This 3-year prospective, randomized, control, longitudinal study is aimed to (1) examine the effect of stair stepping exercise training on cardiopulmonary fitness and sleep situation in patients with Obstructive Sleep Apnea Syndrome (OSAS), and (2) follow the longitudinal change after stair stepping exercise training in patients with OSAS. Patients meet the following criteria will be invited to participate in this study: being diagnosed with AHI (Apnea-hypopnea index)>15/hr and ODI (oxygen desaturation index)>10/hr by Polysomnography, aged 19 or older. Based on the power analysis, 70 patients with OSAS treated in the outpatient department of Chang Gung Medical Center will be recruited over a period of 26 months. Each patient will participate in this study for seventeen weeks. Patients will be randomly assigned to receive stair stepping exercise in addition to nursing education and standard care, or nursing education and standard care alone. Stair stepping exercise will be performed at home daily for eight weeks. Outcomes will be determined by changes in the scores of cardiopulmonary fitness index, VO2max, six-minute walking distance, daytime sleepiness measured by Epworth Sleepiness Scale, sleep time measured by Actigraphy, and AHI measured by Polysomnography; those taken four times: before treatment (baseline), five weeks, nine weeks, and seventeen weeks of the study. Data will be analyzed using descriptive statistics and Generalized Estimating Equation (GEE).
Detailed Description
This study seeks to verify improvements of the stair stepping exercise training on cardiopulmonary fitness condition and sleep condition in patients with obstructive sleep apnea syndrome (OSAS). The quasi-experimental, two group repeated-measures study design was used. Patients meet the following criteria were invited to participate in this study: being diagnosed with AHI (Apnea-hypopnea index)>15/hr and ODI (oxygen desaturation index)>10/hr by Polysomnography, aged 19 or older. Eighteen patients with OSAS treated in the outpatient department of Chest Medicine were recruited, included study group and control group .The study group patients performed stair stepping exercise training daily for eight weeks at home. Outcome measures included cardiorespiratory fitness condition assessed by the 3-Minute YMCA Step Test, in which including physical fitness index and gross oxygen consumption (VO2), and sleep condition assessed by Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Polysomnography. Data were recorded just prior to the stair stepping exercise at Day 1 as baseline, at the end of the fourth week, and at the end of the eighth week. Results of this study showed, physical fitness index, Epworth Sleepiness Scale , AHI, Pittsburgh Sleep Quality Index and symptom scale-snoring were significantly improved. Differences in the effect of stair stepping exercise for other outcome variables were either minimal or not statistically significant. Eight weeks of stair stepping exercise training could be useful in increasing cardiorespiratory fitness condition and improving sleep condition on patients with OSAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
Stair stepping training, OSAS, cardiopulmonary fitness, sleep disturbance, Actigraphy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
stair stepping exercise
Intervention Description
Stair stepping exercise performed at home daily for eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being diagnosed with AHI (Apnea-hypopnea index)>15/hr and ODI (oxygen desaturation index)>10/hr by Polysomnography
aged 19 or older
Exclusion Criteria:
unstable angina
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suh-Hwa Maa, DSN
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome
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