NCT05944536

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

July 6, 2023

Last Update Submit

July 6, 2023

Conditions

Substance Use Disorders

Keywords

Substance AbuseBalance ExerciseDual Task

Outcome Measures

Primary Outcomes (1)

  • Dual Task Timing

    the effect of dual tasks given alongside balance exercises on balance

    8 weeks

Study Arms (2)

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.

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

Other: BE + Dual Task

Interventions

Balance Exercises (BE)OTHER

Each exercise was performed with 10 repetitions for both lower limbs.

Balance Exercise (BE)
BE + Dual TaskOTHER

Cognitive and motor secondary tasks were given

BE+Dual Task

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (13)

  • 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.

    PMID: 25576185BACKGROUND

  • Robertson 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.

    PMID: 26503310BACKGROUND

  • Colledge 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.

    PMID: 28143679BACKGROUND

  • Wang 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.

    PMID: 33101132BACKGROUND

  • Gligoroska 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.

    PMID: 23678325BACKGROUND

  • Prasertsakul 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.

    PMID: 30227884BACKGROUND

  • Walaszek 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.

    PMID: 28869638BACKGROUND

  • Gungen 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.

    PMID: 12794644BACKGROUND

  • Filipa 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.

    PMID: 20710094BACKGROUND

  • MacLeod 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.

    PMID: 2034749BACKGROUND

  • Sousa 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.

    PMID: 16254902BACKGROUND

  • Gribble 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.

    PMID: 22892416BACKGROUND

  • Sinaei, 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Ertuğrul Demirdel, PhD

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

  • Beyza Gül Aşkın, MsC

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ertuğrul Demirdel, PhD

CONTACT

905378223551ertudemirdel@yahoo.com

Beyza Gül Aşkın, MsC Student

CONTACT

905433153710beyzaaskin@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients who the inclusion criteria and agreed to participate were randomly allocates to Group 1 \[Balance Exercises(BE)\] and Group 2 \[BE+Dual Tasks(DT)\]
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 13, 2023

Study Start

March 15, 2021

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)