Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00952172
First received: August 3, 2009
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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).


Condition Intervention Phase
Sleep Apnea Syndrome
Behavioral: stair stepping exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Stair Stepping Exercise Training on Cardiopulmonary Fitness and Sleep Situation in Patients With Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Enrollment: 47
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: stair stepping exercise
    Stair stepping exercise performed at home daily for eight weeks
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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952172

Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Suh-Hwa Maa, DSN Chang Gung University
  More Information

No publications provided

Responsible Party: Chang Gung University, School of Nursing
ClinicalTrials.gov Identifier: NCT00952172     History of Changes
Other Study ID Numbers: 95-2314-B-182-032-MY3, CGMH-IRB-94-935B
Study First Received: August 3, 2009
Last Updated: August 4, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Stair stepping training
OSAS
cardiopulmonary fitness
sleep disturbance
Actigraphy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014