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Single and Dual Task Balance Exercises in Substance Use Disorders

Primary Purpose

Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Balance Exercises (BE)
BE + Dual Task
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance Abuse, Balance Exercise, Dual Task

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being literate, Having a diagnosis of alcohol and substance use disorder according to The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), More than 1 year of substance abuse, Receiving treatment within the scope of the fight against addiction, Not participating in a regular exercise program in the last six months. Exclusion Criteria: Scoring 23 and below on the Mini Mental Test, Having a neurodevelopmental or neurocognitive disorder, Being under the influence of drugs or alcohol in a way that negatively affects the person's -cognitive functions, Having a psychiatric disorder that requires treatment other than opiate and tobacco use disorder according to DSM-5 diagnostic criteria, Cognitive impairment due to mental retardation, drug/substance abuse or other medical condition that may cause difficulty in understanding the study instructions, Being diagnosed with any orthopedic, neurological and systemic disease, Having an active infection, Having problems with vision and hearing.

Sites / Locations

  • Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Physical Therapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Balance Exercise (BE)

BE+Dual Task

Arm Description

Balance exercises; static standing on flat ground for 30 seconds, standing in tandem position for 30 seconds, standing on one foot for 30 seconds, standing on tiptoe for 30 seconds, looking left and right with one foot in the air, backward rotation with one foot in the air, rotation, squatting slightly in knee flexion with one foot in the air, squatting slightly in knee extension with one foot in the air, going on tiptoe and turning with the heel, multi-directional stretches on the balance board Each exercise will be performed with 10 repetitions for both lower extremities.

Cognitive and motor secondary tasks were given along with balance exercises. Cognitive tasks: color discrimination, counting city names, counting fruit and vegetable names, saying 3 numbers between 50-100, talking on a mobile phone, subtracting 3 and 7 in series, saying male names, counting backwards out loud, asking for a series of addition and subtraction operations. Motor tasks: carrying a glass of water, carrying a glass on a tray, carrying an object, pressing a button, transferring money from hand to hand, rhythmic clapping

Outcomes

Primary Outcome Measures

Dual Task Timing
the effect of dual tasks given alongside balance exercises on balance

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 6, 2023
Sponsor
Ankara Yildirim Beyazıt University
Collaborators
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05944536
Brief Title
Single and Dual Task Balance Exercises in Substance Use Disorders
Official Title
The Effects of Single and Dual Task Balance Exercises in Substance Use Disorders: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University
Collaborators
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Changes in the brain reward pathway and brain tissue in alcohol and substance addiction cause balance disorders, cognitive problems, depression, and substance cravings in individuals. The aim of this study is to examine the effects of balance exercises and dual task balance exercises in individuals with alcohol or substance addiction who are receiving treatment.
Detailed Description
This randomized controlled trial was conduces in Ankara Training and Research Hospital, Alcohol and Substance Addiction Treatment Center, Turkey. Individuals who used substances for more than 1 year, between the ages of 18-50 and with a Mini-Mental State Examination score of 24 and above were included in the study. Individuals with orthopedic, neurological or systemic disease, problem with vision and hearing, a neurodevelopmental or neurocognitive disorder and active infection were excluded from the study. In addition, individuals under the effect of substances that negatively affect their cognitive functions were not included in the study. Before starting the study, the Mini-Mental State Examination was used to determine that the individuals were at a cognitive level to complete the tests to be applied. The demographic characteristics of the individuals were saved. The Stroop Test-Çapa Form was used to evaluate executive functions. Y Balance Test, Time Up Go Test and 10 meter walk test were used to evaluate balance. Patients were randomly divided into 2 groups. The first group received only balance exercise and the second group received balance exercise with motor and cognitive dual tasks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance Abuse, Balance Exercise, Dual Task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who the inclusion criteria and agreed to participate were randomly allocates to Group 1 [Balance Exercises(BE)] and Group 2 [BE+Dual Tasks(DT)]
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balance Exercise (BE)
Arm Type
Active Comparator
Arm Description
Balance exercises; static standing on flat ground for 30 seconds, standing in tandem position for 30 seconds, standing on one foot for 30 seconds, standing on tiptoe for 30 seconds, looking left and right with one foot in the air, backward rotation with one foot in the air, rotation, squatting slightly in knee flexion with one foot in the air, squatting slightly in knee extension with one foot in the air, going on tiptoe and turning with the heel, multi-directional stretches on the balance board Each exercise will be performed with 10 repetitions for both lower extremities.
Arm Title
BE+Dual Task
Arm Type
Experimental
Arm Description
Cognitive and motor secondary tasks were given along with balance exercises. Cognitive tasks: color discrimination, counting city names, counting fruit and vegetable names, saying 3 numbers between 50-100, talking on a mobile phone, subtracting 3 and 7 in series, saying male names, counting backwards out loud, asking for a series of addition and subtraction operations. Motor tasks: carrying a glass of water, carrying a glass on a tray, carrying an object, pressing a button, transferring money from hand to hand, rhythmic clapping
Intervention Type
Other
Intervention Name(s)
Balance Exercises (BE)
Intervention Description
Each exercise was performed with 10 repetitions for both lower limbs.
Intervention Type
Other
Intervention Name(s)
BE + Dual Task
Intervention Description
Cognitive and motor secondary tasks were given
Primary Outcome Measure Information:
Title
Dual Task Timing
Description
the effect of dual tasks given alongside balance exercises on balance
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being literate, Having a diagnosis of alcohol and substance use disorder according to The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), More than 1 year of substance abuse, Receiving treatment within the scope of the fight against addiction, Not participating in a regular exercise program in the last six months. Exclusion Criteria: Scoring 23 and below on the Mini Mental Test, Having a neurodevelopmental or neurocognitive disorder, Being under the influence of drugs or alcohol in a way that negatively affects the person's -cognitive functions, Having a psychiatric disorder that requires treatment other than opiate and tobacco use disorder according to DSM-5 diagnostic criteria, Cognitive impairment due to mental retardation, drug/substance abuse or other medical condition that may cause difficulty in understanding the study instructions, Being diagnosed with any orthopedic, neurological and systemic disease, Having an active infection, Having problems with vision and hearing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ertuğrul Demirdel, PhD
Phone
905378223551
Email
ertudemirdel@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beyza Gül Aşkın, MsC Student
Phone
905433153710
Email
beyzaaskin@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Beyza Gül Aşkın, MsC
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, PhD
Phone
905378223551
Email
ertudemirdel@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://doi.org/10.1016/B978-0-323-60913-5.00005-2
Description
Clinical Assessment of Gait

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Single and Dual Task Balance Exercises in Substance Use Disorders

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