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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorBartın Unıversity

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Nephropathy

Retinopathy

Having dementia or Alzheimer's disease

Using a walking aid

Trial design

Design model

Parallel

Treatments tested in this trial

  • dual task exercise group

    Other intervention

    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.

  • single task group

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: dual task exercise groupExperimental treatment 1 intervention
Group B: single task exercise groupActive comparator 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
In 2 weeks
2

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.

Time frame
In 2 weeks

Secondary outcomes

1

Functional Reaching Test

The individual's limits of stability will be assessed by measuring the distance of forward reach while standing still. Prior to the assessment, a 122 cm tape measure will be attached to the wall at the level of the participant's acromion. The participant will be instructed to raise their right arm to 90° of flexion and make a fist. Initially, the starting point, marked by the position of the participant's 3rd metacarpal, will be measured and recorded. The participant will then be asked to reach as far as possible without stepping forward or touching the wall, while keeping their fist parallel to the tape measure. The point where the 3rd metacarpal reaches will be measured and recorded as the final reach distance.

Time frame
In 2 weeks
2

Single-Leg Stance Test

First, the participant will be asked which foot they prefer to stand on or which foot makes them feel more stable. Then, they will be instructed to distribute their weight evenly on both feet and, while maintaining this position, lift one foot off the ground. The timer will start as soon as the participant lifts their foot. The timer will be stopped if any signs of balance disturbance occur, such as the lifted foot making contact with the ground, the standing foot jumping, or the participant needing to support themselves in order to maintain balance.

Time frame
In 2 weeks
3

Maximal exercise test

Pre-exercise stress testing in asymptomatic adults with type 2 diabetes mellitus is a controversial topic. However, the American College of Sports Medicine recommends maximal exercise stress testing for individuals with diabetes over the age of 40, regardless of the presence of cardiovascular disease risk factors. In our study, the maximal exercise test will be performed on a treadmill under medical supervision to assess the risk of complications, and it will be conducted only before the exercise training program. The test will be carried out according to the Modified Bruce protocol.

Time frame
In 2 weeks
4

Functional exercise capacity Functional Exercise Capacity

Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). The participants will be instructed to walk at their maximum comfortable pace for 6 minutes along a 30-meter long, flat, and uninterrupted corridor. At the end of the test, the endpoint will be marked, and the total distance walked will be calculated.

Time frame
In 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bartın Unıversity

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator