The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life

NCT06721429 | Recruiting

• 1 other identifier: BARU-FTR-GM-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of dual-task training on balance, exercise capacity, cognitive function, and quality of life in individuals with Type 2 Diabetes Mellitus (DM). As a result of this study, it is hoped that dual-task training will be an alternative to single-task training in the rehabilitation of individuals with Type 2 DM, with the goal of preventing falls and supporting a more active lifestyle. Additionally, it is intended to include dual-task training in preventive physiotherapy approaches. The main questions the study aims to answer are as follows: Is dual-task training, conducted concurrently with exercise training, more effective in improving balance when compared to exercise training alone and the control group? Is dual-task training, conducted concurrently with exercise training, more effective in improving exercise capacity, cognitive function, and quality of life when compared to exercise training alone and the control group? The researchers will compare the effects of dual-task training in individuals with Type 2 diabetes by comparing the participants in the single-task exercise training group and the control group. Participants will be randomized into the dual-task exercise training group, the single-task exercise training group, and the control group. Individuals in the training group will undergo exercise training three days a week for 8 weeks.

Conditions

Diabetes Mellitus, Type 2

Keywords

exercise; balance; exercise tolerance; Mental Status

Outcome Measures

Primary Outcomes (2)

• Time Up and Go Test

  This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.

  In 2 weeks

• Berg Balance Scale

  It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.

  In 2 weeks

Secondary Outcomes (15)

• Functional Reaching Test

  In 2 weeks

• Single-Leg Stance Test

  In 2 weeks

• Maximal exercise test

  In 2 weeks

• Functional exercise capacity Functional Exercise Capacity

  In 2 weeks

• Timed Up and Go Test (Cognitive)

  In 2 weeks

Study Arms (3)

dual task exercise group

EXPERIMENTAL

Patients in the dual-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attention.

Other: dual task exercise group

single task exercise group

ACTIVE COMPARATOR

Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.

Other: single task group

control group

NO INTERVENTION

The control group will be instructed to continue with their daily activities and refrain from participating in any exercise training program for eight weeks after the initial assessment. After the exercise training period, the control group will also be invited to join the exercise training program of their choice.

Interventions

dual task exercise group OTHER

Dual task exercise group Patients in the dual-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attentioN Single task exercise group Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.

dual task exercise group

single task group OTHER

Single task exercise group Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.

single task exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Being followed up with a diagnosis of Type 2 Diabetes Mellitus for at least 6 months (fasting plasma glucose of 7.0 mmol/L or higher)
• Not having participated in any structured exercise program for at least 6 months prior.
• Being willing to volunteer for the study

You may not qualify if:

• Nephropathy
• Retinopathy
• Having dementia or Alzheimer's disease
• Using a walking aid
• Having ulceration
• Using balance-curing drugs
• Surviving myocardial infarction at least 6 months ago
• Stable or unstable angina pectoris
• Left ventricular ejection fraction below 40%
• Peripheral arterial diseases
• Resting blood pressure above 160/100 mmHg
• Body mass index above 35 kg/m2
• Having a history of deep vein thrombosis, pulmonary embolism or stroke in the past

Sponsors & Collaborators

• Bartın Unıversity: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bartın University

Bartın, 74000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Villafaina S, Collado-Mateo D, Dominguez-Munoz FJ, Fuentes-Garcia JP, Gusi N. Impact of adding a cognitive task while performing physical fitness tests in women with fibromyalgia: A cross-sectional descriptive study. Medicine (Baltimore). 2018 Dec;97(51):e13791. doi: 10.1097/MD.0000000000013791.

  PMID: 30572536 BACKGROUND

• Shellington EM, Reichert SM, Heath M, Gill DP, Shigematsu R, Petrella RJ. Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning. Can J Diabetes. 2018 Dec;42(6):603-612.e1. doi: 10.1016/j.jcjd.2018.02.003. Epub 2018 Mar 6.

  PMID: 29884522 BACKGROUND

• Beauchet O, Dubost V, Aminian K, Gonthier R, Kressig RW. Dual-task-related gait changes in the elderly: does the type of cognitive task matter? J Mot Behav. 2005 Jul;37(4):259-64.

  PMID: 15967751 BACKGROUND

• Tard C, Dujardin K, Girard A, Debaughrien M, Derambure P, Defebvre L, Delval A. How does visuospatial attention modulate motor preparation during gait initiation? Exp Brain Res. 2016 Jan;234(1):39-50. doi: 10.1007/s00221-015-4436-0. Epub 2015 Sep 10.

  PMID: 26358126 BACKGROUND

• Park JH. Is Dual-Task Training Clinically Beneficial to Improve Balance and Executive Function in Community-Dwelling Older Adults with a History of Falls? Int J Environ Res Public Health. 2022 Aug 17;19(16):10198. doi: 10.3390/ijerph191610198.

  PMID: 36011833 BACKGROUND

• Zhang J, Tam WWS, Hounsri K, Kusuyama J, Wu VX. Effectiveness of Combined Aerobic and Resistance Exercise on Cognition, Metabolic Health, Physical Function, and Health-related Quality of Life in Middle-aged and Older Adults With Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Aug;105(8):1585-1599. doi: 10.1016/j.apmr.2023.10.005. Epub 2023 Oct 22.

  PMID: 37875170 BACKGROUND

• Callisaya ML, Daly RM, Sharman JE, Bruce D, Davis TME, Greenaway T, Nolan M, Beare R, Schultz MG, Phan T, Blizzard LC, Srikanth VK. Feasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial. BMC Geriatr. 2017 Oct 16;17(1):237. doi: 10.1186/s12877-017-0635-9.

  PMID: 29037162 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• gizem mermerkaya

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gizem mermerkaya

CONTACT

+905455850238; gizmyagiz@gmail.com

gizem mermerkaya

CONTACT

gizmyagiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: This study will include 36 patients with type 2 diabetes mellitus. Patients who meet the inclusion criteria will be randomly assigned to one of three groups: the dual-task exercise training group (n=12), the single-task exercise training group (n=12), or the control group (n=12).In the single-task exercise training group, aerobic exercise, resistance training, and balance training will be performed as separate tasks, while in the dual-task training group, these same exercises will be performed simultaneously with cognitive dual-task training. The control group will be instructed to continue with their daily activities and refrain from participating in any exercise training program for eight weeks after the initial assessment. In the exercise training groups, individuals will undergo a combined exercise program consisting of aerobic exercise, resistance training, and balance training, with three sessions per week on non-consecutive days over a period of 8 weeks, totaling 24 sessions.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 25, 2024
• Primary Completion: February 3, 2025
• Study Completion: May 28, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)