Effects of Core Stabilization Exercises on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity

Study Overview
=================
Brief Summary
-----------------
In recent years adolescent substance abuse is a serious and growing problem. Substance use among adolescents means the use of alcohol, opiates, amphetamines, inhalants, cocaine, marijuana, benzodiazepines, hallucinogens, and anabolic steroids. The United Nations Office on Drugs and Crime reports that approximately 5% of the world's population used an illicit drug in 2010 and it is estimated that heroin, cocaine and other drugs are responsible for 0.1 to 0.2 million deaths per year. There is a limited number of studies in the literature that investigate the relationship between substance use disorder and respiratory functions. In Taylor et al., study reported that the proportion of cannabis-dependent study members with an FEV1/FVC ratio of, 80% was 36% compared to 20% for non-smokers. Another research of Taylor et al., in longitudinal observations over 8 years in young adults (cannabis smoking on lung function in young adults between the ages of 18 and 26) revealed a dose-dependent relationship between cumulative cannabis consumption and decline in FEV1/VC. In a monograph, stated that follow-up studies of regular cannabis-only smokers also found impaired respiratory function and pathological changes in lung tissue like those preceding the development of chronic obstructive pulmonary disease . The core anatomically described as a box, with the abdominals at the front, spinal and gluteal muscles at the back, the diaphragm on the top, and the pelvic floor and hip muscles on the bottom. Correct breathing is vital to abdominal training because respiratory muscles are directly involved during common core stability exercises. Moreover, the diaphragm, a component of core stability, plays a role in respiration and trunk stability by controlling intra-abdominal pressure . Oh et al.reported that, 30-min, 3 days a week for 8 weeks lumbar stabilization exercise had a more positive effect on pulmonary function than general physical therapy on stroke patients. Our hypothesis was that core exercises may positive effect on respiratory functions and functional capacity of substance use disorder individuals. The aim of our study is to investigate the effects of core exercises on respiratory functions and functional capacity in adolescents with substance use disorder.

Detailed Description
-----------------
Subjects: The study sample comprised of 15-18 year old male. Participants were required to be in-residence at the treatment center and meet Diagnostic and Statistical Manual-V criteria for substance use disorder in Mental Health and Neurological Diseases Training and Research Hospital for Psychiatry, Neurology and Neurosurgery; Child and Adolescent Drug and Alcohol Dependence Treatment Center (CEMATEM) in Istanbul. Sample Size Determination: The sample size and power calculations were performed using the Instat sample size calculator. The calculations were based on the average value of the 6-Minute Walk Test in the 15-20 age group was 725.8 meters and the standard deviation (SD) was 61.2 meters (28), in the 95% confidence interval, an alpha level of 0.05, a β level of 5% and a power of 95%.These parameters generated a sample size of at least 18 participants for each group. Randomization Study Protocol: The participants were randomly assigned to 1 of 2 parallel groups to receive either Exercise or Control. To allocate the participants to the groups, using the method of randomly permuted blocks using Research Randomizer, a program published on a publicly accessible official website (www.randomizer.org). Computerized random numbers were conducted, and sequentially numbered index cards with the random assignment were prepared. The index cards were folded and placed in sealed, opaque envelopes. Then, the investigator opened each envelope and allocated the participants to the Exercise or control group according to the selected index card.

Official Title
-----------------
Effects of Core Stabilization Exercises on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Adolescents With Substance Use Disorder. A Randomized Controlled Study

Conditions
-----------------
Substance Use Disorders, Substance Abuse, Substance Use

Intervention / Treatment
-----------------
* Other: Exercise group
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were between 15 and 18 years of age, met current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for substance use disorder, be using substances over a year, have not participated regularly in any exercise training program for the past six months, were currently engaged in inpatient substance abuse treatment. Exclusion Criteria: a history of psychotic disorder or current psychotic symptoms, physical disabilities or medical problems, inability to adapt to the evaluation and treatment program, have a respiratory system problems such as bronchiectasis, asthma and tuberculosis, infectious health problem (HIV, hepatitis B etc.).

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>In addition to the service routine rehabilitation program, in this group all participant receive as group training with instructor supervising 5-6 participants. The specific days of the week and time of day in which the participants trained remained constant throughout each training protocol. Training programs lasted 6 weeks and comprised 2 training sessions per week with a total of 12 training sessions. A 45-60 min training sessions per week with a 2 day gap between each session. | Other: Exercise group<br>* Exercise group mainly conducted the 5 core stabilization exercises as described by McGill. These include the curl-up, side bridge, trunk extension, double leg lifts and bird-dog exercises that support respiratory functions. In other words, every single training session consisted of frontal, dorsal, and lateral core exercise. In general, participants always exercised in group so that for integration and motivation. During training weeks 1-2, participants exercises with 3 sets per exercise and 10 s contraction time and 10 repetitions. During training weeks 3-4, contraction times and repetitions were increased to 15 s and 15 repetitions. Additionally, increasing the complexity of exercises, adding opposite limb movements and increasing the lever arm of the exercises were done.<br>* Other names: Core stabilization exercise;|
| Other: Control Group<br>In addition to the service routine rehabilitation program, participants in the Control group participated in leisure activities such as table tennis/basketball under service staff supervision for 45-60 minutes, 2 times a week, 6 weeks similar time period of Exercise group. | Other: Control group<br>* In addition to the service routine rehabilitation program mentioned above, participants in the Control group participated in leisure activities such as table tennis/basketball under service staff supervision for 45-60 minutes, 2 times a week, 6 weeks similar time period of Exercise group.<br>* Other names: Aerobic exercise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Test | Pulmonary functions were measured using portable spirometry (Spirobank II; Medical International Research Rome, Italy). Measurements were performed according to the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines. | 6 weeks | 
| Maximal Inspiratory and Expiratory Pressures | Participants' maximal inspiratory and expiratory pressures was measured and recorded according to ATS/ERS criteria using a portable, electronic intraoral pressure gauge (Carefusion, USA) . During the test, subjects were encouraged verbally. Technically acceptable, the highest of at least three measurements that did not differ by more than 5 cm H2O was recorded for maximal inspiratory and expiratory pressures. A percentages of the predicted values of maximal inspiratory and expiratory pressures were expressed as described by Black and Hyatt. | 6 weeks | 
| Functional Capacity | Functional capacity was measured with the 6-Minute Walk Test (6MWT) according to the guideline of ERS. The 6MWT to be a reliable, reproducible, and valid functional test for assessing exercise tolerance and endurance. Subjects were instructed to walk from one end to the other of a 30 m hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 min. The test was self-paced and the subject could rest if he or she so wished. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Related Symptoms | Respiratory related symptoms were assessed by using the respiratory section of the third National Health Nutrition Examination Survey (NHANES III) and the Medical Research Council breathlessness questionnaire were used to record reported respiratory symptoms. Questionnaires were given as face-to-face interviews by one investigator in a standardised manner. | 6 weeks | 
| The Modified Medical Research Council (mMRC) Dyspnoea Scale | The Medical Research Council (MRC) dyspnoea scale has been in use for many years for grading the effect of breathlessness on daily activities. This scale actually measures perceived respiratory disability, the World Health Organization definition of disability being any restriction or lack of ability to perform an activity in the manner or within the range considered normal for a human being. The MRC dyspnoea scale is simple to administer as it allows the patients to indicate the extent to which their breathlessness affects their mobility. The person indicates the degree of breathlessness with a score of 0-4. Level 0 refers to there is not breathless, level 4 refers to there is a severe breathless. | 6 weeks | 
| The Fagerstrom Test of Nicotine Dependence (FTND) | The FTND is a widely used 6-item scale with high test-retest validity. The nicotine dependence of the total score obtained from the test,low (0-3 points), moderate (4-6 points) and high (≥7 points). | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary function, respiratory muscle strength, functional capacity, core exercises, rehabilitation