Clinical Trials Directory

Trials / Completed

CompletedNCT03461614

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Istanbul University · Academic / Other
Sex
Male
Age
15 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExercise groupExercise 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.
OTHERControl groupIn 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.

Timeline

Start date
2017-02-01
Primary completion
2018-04-05
Completion
2018-04-05
First posted
2018-03-12
Last updated
2018-04-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03461614. Inclusion in this directory is not an endorsement.