- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952172
Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome
August 4, 2009 updated by: Chang Gung Memorial Hospital
Effectiveness of Stair Stepping Exercise Training on Cardiopulmonary Fitness and Sleep Situation in Patients With Obstructive Sleep Apnea Syndrome
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Suh-Hwa Maa, DSN, Chang Gung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (ESTIMATE)
August 6, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 6, 2009
Last Update Submitted That Met QC Criteria
August 4, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95-2314-B-182-032-MY3
- CGMH-IRB-94-935B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Apnea Syndrome
-
University of ChicagoGlaxoSmithKlineCompletedChildhood Obstructive Sleep Apnea Syndrome (OSAS)United States
-
University Hospital, MontpellierCompletedComplex Sleep Apnea Syndrome | Chronic Heart Failure and | Obstructive Sleep Apnea Syndrome and | Idiopathic Central Sleep Apnea Syndrome | Idiopathic Induced Periodic Breathing | Central Sleep Apnea SyndromeFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingModerate Obstructive Sleep Apnea SyndromeFrance
-
Karolinska University HospitalCompletedObstructive Sleep Apnea Syndrome in ChildrenSweden
-
University of Alabama at BirminghamTerminatedObstructive Sleep Apnea Hypopnea Syndrome (OSAHS)United States
-
Sakarya UniversityUnknown
-
Royal College of Surgeons, IrelandUniversity College Dublin; Connolly Hospital BlanchardstownCompletedObstructive Sleep Apnoea SyndromeIreland
-
Sleepinnov TechnologyUniversity Hospital, Grenoble; ICUREsearchCompletedObstructive Sleep Apnea SyndromeFrance
-
LivaNovaNational Research Agency, FranceCompletedObstructive Sleep Apnea SyndromeFrance
-
Uskudar UniversityCompleted
Clinical Trials on stair stepping exercise
-
San Diego State UniversityRecruitingPostprandial Hyperglycemia | Postprandial Glycemic Response | Postprandial InsulinUnited States
-
Teesside UniversityCompletedBlood Pressure | Heart Rate | Physical Activity Enjoyment | High-intensity Interval Exercise | Rating of Perceived Exertion | Acute MoodUnited Kingdom
-
San Diego State UniversityRecruiting
-
KU LeuvenCompleted
-
National Yang Ming UniversityUnknown
-
New York Institute of TechnologyRecruitingPhysical Therapy | Rehabilitation ExerciseUnited States
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedKnee Osteoarthritis
-
National Yang Ming UniversityUnknownCognitive Function | Executive Function | Amnestic Mild Cognitive Impairment | Memory | Interactive Stepping Exercise
-
Fenerbahce UniversityNot yet recruitingExercise | Cognitive Function | Aerobic Exercise | Physical Fitness | Square Step ExercisesTurkey
-
Kaohsiung Veterans General Hospital.CompletedChronic Stroke Patients