Substance Use DisordersNCT05944536
Single and Dual Task Balance Exercises in Substance Use Disorders
A study testing Balance Exercises (BE) and BE + Dual Task in people with Substance Use Disorders, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Balance Exercises (BE) and BE + Dual Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation
Ankara
Ertuğrul Demirdel, PhD, 905378223551, ertudemirdel@yahoo.com
About this study
Official title: The Effects of Single and Dual Task Balance Exercises in Substance Use Disorders: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Balance Exercises (BE), BE + Dual Task
- Keywords
- Substance Abuse, Balance Exercise, Dual Task
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Exercises (BE)Other
Each exercise was performed with 10 repetitions for both lower limbs.
BE + Dual TaskOther
Cognitive and motor secondary tasks were given
| Study group | Role | What they receive |
|---|---|---|
| Balance Exercise (BE) | Active comparator | 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. Receives: Other: Balance Exercises (BE) |
| BE+Dual Task | Experimental | 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 Receives: Other: BE + Dual Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Task Timing
the effect of dual tasks given alongside balance exercises on balance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Mar 2021
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Ertuğrul Demirdel, PhD, Study director, Ankara Yildirim Beyazıt UniversityBeyza Gül Aşkın, MsC, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944536
- Sponsor's protocol ID
- 2022
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss NH, Gratz KL, Lavender JM. Factor Structure and Initial Validation of a Multidimensional Measure of Difficulties in the Regulation of Positive Emotions: The DERS-Positive. Behav Modif. 2015 May;39(3):431-53. doi: 10.1177/0145445514566504. Epub 2015 Jan 9.
PubMed 25576185Robertson CL, Ishibashi K, Chudzynski J, Mooney LJ, Rawson RA, Dolezal BA, Cooper CB, Brown AK, Mandelkern MA, London ED. Effect of Exercise Training on Striatal Dopamine D2/D3 Receptors in Methamphetamine Users during Behavioral Treatment. Neuropsychopharmacology. 2016 May;41(6):1629-36. doi: 10.1038/npp.2015.331. Epub 2015 Oct 27.
PubMed 26503310Colledge F, Vogel M, Dursteler-Macfarland K, Strom J, Schoen S, Puhse U, Gerber M. A pilot randomized trial of exercise as adjunct therapy in a heroin-assisted treatment setting. J Subst Abuse Treat. 2017 May;76:49-57. doi: 10.1016/j.jsat.2017.01.012. Epub 2017 Jan 29.
PubMed 28143679Wang D, Zhu T, Chen J, Lu Y, Zhou C, Chang YK. Acute Aerobic Exercise Ameliorates Cravings and Inhibitory Control in Heroin Addicts: Evidence From Event-Related Potentials and Frequency Bands. Front Psychol. 2020 Sep 29;11:561590. doi: 10.3389/fpsyg.2020.561590. eCollection 2020.
PubMed 33101132Gligoroska JP, Manchevska S. The effect of physical activity on cognition - physiological mechanisms. Mater Sociomed. 2012;24(3):198-202. doi: 10.5455/msm.2012.24.198-202.
PubMed 23678325Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.
PubMed 30227884Walaszek R, Chwala W, Walaszek K, Burdacki M, Blaszczuk J. Evaluation of the accuracy of the postural stability measurement with the Y-Balance Test based on the levels of the biomechanical parameters. Acta Bioeng Biomech. 2017;19(2):121-128.
PubMed 28869638Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Filipa A, Byrnes R, Paterno MV, Myer GD, Hewett TE. Neuromuscular training improves performance on the star excursion balance test in young female athletes. J Orthop Sports Phys Ther. 2010 Sep;40(9):551-8. doi: 10.2519/jospt.2010.3325.
PubMed 20710094MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
PubMed 2034749Sousa N, Sampaio J. Effects of progressive strength training on the performance of the Functional Reach Test and the Timed Get-Up-and-Go Test in an elderly population from the rural north of Portugal. Am J Hum Biol. 2005 Nov-Dec;17(6):746-51. doi: 10.1002/ajhb.20446.
PubMed 16254902Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
PubMed 22892416Sinaei, E., Kamali, F., Nematollahi, A., Etminan, Z. Comparing the effects of balance training with and without cognitive tasks on the quality of life and balance performance in community-dwelling older adults: a single-blind randomized clinical trial. Journal of Rehabilitation Sciences & Research, 2016; 3(4): 91-96. doi: 10.30476/jrsr.2016.41106
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Single and Dual Task Balance Exercises in Substance Use Disorders: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05944536
- Acronym / sponsor ID
- 2022
- Conditions
- Substance Use Disorders
- Keywords
- Substance Abuse, Balance Exercise, Dual Task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)]
| Arm | Type | Receives |
|---|---|---|
| Balance Exercise (BE) | Active comparator | Other: Balance Exercises (BE)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. |
| BE+Dual Task | Experimental | Other: BE + Dual TaskCognitive 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance Exercises (BE)Each exercise was performed with 10 repetitions for both lower limbs. | Other | Balance Exercise (BE) |
| BE + Dual TaskCognitive and motor secondary tasks were given | Other | BE+Dual Task |
Primary outcome
Dual Task Timing
Time frame: 8 weeks
the effect of dual tasks given alongside balance exercises on balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 25576185Weiss NH, Gratz KL, Lavender JM. Factor Structure and Initial Validation of a Multidimensional Measure of Difficulties in the Regulation of Positive Emotions: The DERS-Positive. Behav Modif. 2015 May;39(3):431-53. doi: 10.1177/0145445514566504. Epub 2015 Jan 9.
- Background: PubMed 26503310Robertson CL, Ishibashi K, Chudzynski J, Mooney LJ, Rawson RA, Dolezal BA, Cooper CB, Brown AK, Mandelkern MA, London ED. Effect of Exercise Training on Striatal Dopamine D2/D3 Receptors in Methamphetamine Users during Behavioral Treatment. Neuropsychopharmacology. 2016 May;41(6):1629-36. doi: 10.1038/npp.2015.331. Epub 2015 Oct 27.
- Background: PubMed 28143679Colledge F, Vogel M, Dursteler-Macfarland K, Strom J, Schoen S, Puhse U, Gerber M. A pilot randomized trial of exercise as adjunct therapy in a heroin-assisted treatment setting. J Subst Abuse Treat. 2017 May;76:49-57. doi: 10.1016/j.jsat.2017.01.012. Epub 2017 Jan 29.
- Background: PubMed 33101132Wang D, Zhu T, Chen J, Lu Y, Zhou C, Chang YK. Acute Aerobic Exercise Ameliorates Cravings and Inhibitory Control in Heroin Addicts: Evidence From Event-Related Potentials and Frequency Bands. Front Psychol. 2020 Sep 29;11:561590. doi: 10.3389/fpsyg.2020.561590. eCollection 2020.
- Background: PubMed 23678325Gligoroska JP, Manchevska S. The effect of physical activity on cognition - physiological mechanisms. Mater Sociomed. 2012;24(3):198-202. doi: 10.5455/msm.2012.24.198-202.
- Background: PubMed 30227884Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.
- Background: PubMed 28869638Walaszek R, Chwala W, Walaszek K, Burdacki M, Blaszczuk J. Evaluation of the accuracy of the postural stability measurement with the Y-Balance Test based on the levels of the biomechanical parameters. Acta Bioeng Biomech. 2017;19(2):121-128.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Background: PubMed 20710094Filipa A, Byrnes R, Paterno MV, Myer GD, Hewett TE. Neuromuscular training improves performance on the star excursion balance test in young female athletes. J Orthop Sports Phys Ther. 2010 Sep;40(9):551-8. doi: 10.2519/jospt.2010.3325.
- Background: PubMed 2034749MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
- Background: PubMed 16254902Sousa N, Sampaio J. Effects of progressive strength training on the performance of the Functional Reach Test and the Timed Get-Up-and-Go Test in an elderly population from the rural north of Portugal. Am J Hum Biol. 2005 Nov-Dec;17(6):746-51. doi: 10.1002/ajhb.20446.
- Background: PubMed 22892416Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
- Clinical Assessment of GaitLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ertuğrul Demirdel, PhD study director
Ankara Yildirim Beyazıt University
Beyza Gül Aşkın, MsC principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Exercises (BE) and BE + Dual Task in people with Substance Use Disorders, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ertuğrul Demirdel, PhD (905378223551, ertudemirdel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Task Timing (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944536, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.