- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398068
Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Goksen Kuran Aslan, Assoc. Prof.
- Phone Number: 40167 +90 (212) 414 15 28
- Email: goksenkuran@yahoo.com
Study Locations
-
-
-
Istanbul, Turkey, 34320
- Recruiting
- Istanbul University-Cerrahpasa
-
Contact:
- Goksen Kuran Aslan, Assoc. Prof.
- Phone Number: 40167 +90 (212) 414 15 28
- Email: goksenkuran@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >18 years old
- Patients who have been diagnosed with Obesity Hypoventilation Syndrome
Exclusion Criteria:
- Patients who participate in any other diet program
- Patients who are incompatible with a diet program or exercise program
- Patients with uncontrollable respiratory and comorbid diseases
- Patient who have been an orthopedic, neurological, cardiac, or metabolic condition that may prevent participation and continuation of the exercise program throughout the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training (Exercises and Diet) Group
Training (Exercises and Diet) Group; Patients will follow a regular diet program for 10 weeks. Aerobic exercises will be planned for patients 2 days a week under the supervision of a physiotherapist, and 3 days a week as home exercises. Strengthening exercises will be planned for patients 1 days a week under the supervision of a physiotherapist, and 2 days a week as home exercises. |
Non-Invasive Ventilation (NIV) will be included in the treatment program of all patients participating in the study. For the Mediterranean diet protocol planned in training groups; each patient will be evaluated by a dietitian at the beginning of the study and individual diet programs will be planned. A 10-week exercise training will be planned for the training group. Aerobic exercise sessions will be planned as a 5-minute warm-up - 20-minute bicycle ergometer - 5-minute cooling-down program. The intensity of exercise will be planned to be of medium intensity according to the heart rate reserve (40-50%). According to the Modified Borg Scale, walking will be given 3 days a week at a intensity of 4-6, also as a home exercise. Strengthening exercises will be planned with reference to 10 RM (repetition maximum) with theraband for large muscle groups (10 repetitions-3 sets). |
Active Comparator: Control (Diet) Group
Control (Diet) Group; Patients will follow a regular diet program for 10 weeks.
|
Non-Invasive Ventilation (NIV) will be included in the treatment program of all patients participating in the study.
A regular diet program will be planned for 10 weeks for the control group. .
For the Mediterranean diet protocol planned in control groups; each patient will be evaluated by a dietitian at the beginning of the study and individual diet programs will be planned.
After that, after 1 week, patients will be re-evaluated for compliance by a dietitian.
And than, each patient included in the study will be evaluated for 2 weeks during the treatment period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Minutes Walk Test
Time Frame: 10 weeks
|
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes.
The distance that normal individuals should take in this period is 400-700 meters.
In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing.
Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
|
10 weeks
|
Pittsburgh Sleep Quality Index
Time Frame: 10 weeks
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations.
The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders.
Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nottingham Health Profile
Time Frame: 10 weeks
|
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status.
It is a questionnaire designed to measure a patient's view of their own health status, in a number of areas.
The NHP consists of two parts.
The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation.
The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays.
The second part of the NHP is optional and can be omitted without ruining the test results.
|
10 weeks
|
Hospital Anxiety and Depression Scale
Time Frame: 10 weeks
|
7 items of the scale assess anxiety and 7 items assess depression.
The answers, which are evaluated in a three-point Likert format, are scored between 0-3.
When patients scored 0-10 for anxiety, patients were defined as no anxiety, 11 or more anxiety, and 0-7 points for depression as no depression, 8 or more depression.
|
10 weeks
|
Muscle Strength - Dynamometer
Time Frame: 10 weeks
|
A digital dynamometer will be used to evaluate muscle strength.
Muscle strength will be evaluated in the following muscles, each measurement will be made three times and the average will be taken.
|
10 weeks
|
Body Fat Percentage
Time Frame: 10 weeks
|
The body fat percentage of a patient is the total mass of fat divided by total body mass, multiplied by 100; body fat includes essential body fat and storage body fat.
The body fat percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
And results will be recorded in percent.
|
10 weeks
|
Body Fluid Percentage
Time Frame: 10 weeks
|
Body fluids, bodily fluids, or biofluids are liquids within the human body.
The body fluid percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
And results will be recorded in percent.
|
10 weeks
|
Muscle Mass
Time Frame: 10 weeks
|
Muscle mass refers to the amount of soft muscle tissue in the body.
The muscle mass of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
And results will be recorded in kg.
|
10 weeks
|
Bone Mass
Time Frame: 10 weeks
|
Bone mass refers to the amount of bone tissue in the skeleton.
The bone mass of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
And results will be recorded in kg.
|
10 weeks
|
Body Mass Index
Time Frame: 10 weeks
|
Body mass index (BMI) is a value derived from the mass (weight) and height of a person.
The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Disease
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Respiratory Insufficiency
- Sleep Apnea, Obstructive
- Syndrome
- Obesity
- Sleep Wake Disorders
- Respiration Disorders
- Hypoventilation
- Obesity Hypoventilation Syndrome
Other Study ID Numbers
- 2022/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Respiration Disorders
-
Imperial College LondonUnknown
-
University of Milano BicoccaCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Kaohsiung Veterans General Hospital.CompletedRespiratory Failure | Respiration, ArtificialTaiwan
-
Unity Health TorontoCompletedRespiratory Insufficiency | Respiration, ArtificialCanada
-
Medical University InnsbruckCompleted
-
University of BariRecruitingRespiratory Disease | Artificial RespirationItaly
-
University of Sao Paulo General HospitalRecruitingRespiratory Insufficiency | Respiration, Artificial | Ventilation Therapy; Complications | Ventilators, MechanicalBrazil
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedRespiratory Insufficiency | PEEP, Intrinsic | PEEP, OccultItaly
-
Medical University InnsbruckCompletedPositive-Pressure Respiration | Respiration; ArtificialAustria
Clinical Trials on Exercises and Diet
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
Shanghai 6th People's HospitalShanghai Municipal Center for Disease Control and PreventionActive, not recruiting
-
Badr UniversityRecruitingAnorexia in AdolescenceEgypt
-
Cairo UniversityRecruitingCoagulation DisorderEgypt
-
Cairo UniversityRecruitingBreast Cancer | Diet, Healthy | Immune DeficiencyEgypt
-
Bezmialem Vakif UniversityRecruitingOverweight | ExerciseTurkey
-
Cairo UniversityRecruiting
-
Dina Mohamed Tarek Mansour El-kasrawyCompletedStress Urinary IncontinenceEgypt
-
Batterjee Medical CollegeBenha UniversityCompleted