- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190081
Task Training In Older Adults With Age-Related Hearing Loss
Investigation Of the Effects Of Dual-Task And Single-Task Training In Older Adults With Age-Related Hearing Loss
This study aimed to examine the effects of single and dual-task training on physical function, cognitive function, quality of life, balance, concerns about falling, and activities of daily living in the elderly with age-related hearing loss.
The elderly who were diagnosed with age-related hearing loss in Pamukkale University Health, Practice and Research Center, Department of Otorhinolaryngology participated in the study. The elderly were allocated a single-task training group, dual-task training group, and control group. Thirteen patients in the single-task training group, 15 patients in the dual-task training group, 14 patients in the control group completed the study. Degrees of hearing loss were determined by pure tone audiometry. Evaluations, Senior Fitness Test, Montreal Cognitive Assessment, World Health Organization- Quality of Life- Old Module, Berg Balance Scale, Falls Efficacy Scale International, Functional Independence Measure, Dual Task Questionnaire, Dual Task Effect, were performed initially, after the interventions and at the 6th month. The interventions were carried out two days a week and 40 minutes, for five weeks.
Study Overview
Status
Intervention / Treatment
Detailed Description
Outcome Measures Physical function, cognitive function, auditory function, quality of life, balance, concerns about falling, independence in activities of daily living, and dual-task performance were evaluated. Older adults were evaluated initially, after the dual-task and single-task training, and at 6th month for long-term control. All evaluations and interventions were carried out in an isolated and quiet environment in the examination room of the Department of Otorhinolaryngology.
Interventions A special program including motor and cognitive tasks was prepared. Both lower and upper extremity motor tasks and verbal, arithmetic, auditory, and visual cognitive tasks were planned based on evidence. Tasks were completed at the same time in the dual-task training group, were completed separately in the single-task training group. No intervention was performed in the control group. The dual-task and single-task training were held 2 days a week, 40 minutes, for a total of 10 sessions for 5 weeks. A patient-appropriate task was selected for each cognitive task each week. It has been tried to prevent the learning effect by providing individual and weekly progress according to the patients' performance in the tasks in the motor and cognitive parts. Variable priority instructions were used in the dual-task training group, and fixed priority instructions were used in the single-task training group. At the beginning and end of the intervention programs, 7 types of warm-up and cool-down exercises involving large muscle groups were performed for 10-minutes. Each task in the intervention programs was performed for 60 seconds and/or 10 repetitions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kinikli
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Denizli, Kinikli, Turkey, 20070
- Pamukkale University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being >65 years old
- Montreal Cognitive Assessment Scale score > 21
- Diagnosed with Age-Related Hearing Loss
- Having bilateral symmetrical hearing loss (average ±10dB difference)
- Having normal visual functions
- Ability to ambulate independently (may use a self-help device)
Exclusion Criteria:
- Using a hearing aid
- Receiving a physical therapy intervention for Age-Related Hearing Loss
- Having an orthopedic or neurological condition that may affect cognition or postural control
- Using medication that may affect cognition or postural control
- Having vertigo or being hospitalized in the emergency room due to vertigo attacks
- Missing or refusing the follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-task training group
Tasks were completed separately in the single-task training group
|
A special program including motor and cognitive tasks was prepared.
Both lower and upper extremity motor tasks and verbal, arithmetic, auditory, and visual cognitive tasks were planned based on evidence.
The dual-task and single-task training were held 2 days a week, 40 minutes, for a total of 10 sessions for 5 weeks.
A patient-appropriate task was selected for each cognitive task each week.
|
Experimental: dual-task training group
Tasks were completed at the same time in the dual-task training group
|
A special program including motor and cognitive tasks was prepared.
Both lower and upper extremity motor tasks and verbal, arithmetic, auditory, and visual cognitive tasks were planned based on evidence.
The dual-task and single-task training were held 2 days a week, 40 minutes, for a total of 10 sessions for 5 weeks.
A patient-appropriate task was selected for each cognitive task each week.
|
No Intervention: control group
No intervention was performed in the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Senior Fitness Test
Time Frame: Initially, 1st week
|
This test is valid in the elderly population and provides comprehensive, continuous measurement, consisting of 6 sub-heading, including chair stand, arm curl, 2-minute step, chair sit-and-reach, back scratch, and 8-foot-up-and-go tests
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Initially, 1st week
|
Senior Fitness Test
Time Frame: At 5th week
|
This test is valid in the elderly population and provides comprehensive, continuous measurement, consisting of 6 sub-heading, including chair stand, arm curl, 2-minute step, chair sit-and-reach, back scratch, and 8-foot-up-and-go tests
|
At 5th week
|
Senior Fitness Test
Time Frame: Through study completion at 6th month
|
This test is valid in the elderly population and provides comprehensive, continuous measurement, consisting of 6 sub-heading, including chair stand, arm curl, 2-minute step, chair sit-and-reach, back scratch, and 8-foot-up-and-go tests
|
Through study completion at 6th month
|
Montreal Cognitive Assessment
Time Frame: Initially, 1st week
|
It evaluates 8 different cognitive functions: visuospatial/executive functions, naming, attention, concentration and calculation, language, abstraction, delayed recall, and orientation.
The highest score is 30 in total.
A score of 21 and above is considered normal
|
Initially, 1st week
|
Montreal Cognitive Assessment
Time Frame: At 5th week
|
It evaluates 8 different cognitive functions: visuospatial/executive functions, naming, attention, concentration and calculation, language, abstraction, delayed recall, and orientation.
The highest score is 30 in total.
A score of 21 and above is considered normal
|
At 5th week
|
Montreal Cognitive Assessment
Time Frame: Through study completion at 6th month
|
It evaluates 8 different cognitive functions: visuospatial/executive functions, naming, attention, concentration and calculation, language, abstraction, delayed recall, and orientation.
The highest score is 30 in total.
A score of 21 and above is considered normal
|
Through study completion at 6th month
|
Pure tone audiometry
Time Frame: Initially, 1st week
|
Pure tone audiometry at 6 different frequencies (0.5, 1, 2, 4, 6, 8 kHz) frequently mentioned in the literature was performed by an audiologist with a clinical audiometer
|
Initially, 1st week
|
World Health Organization Quality of Life - Old Module
Time Frame: Initially, 1st week
|
It consists of 24 items in six facets.
The facets of this module are "sensory abilities", "autonomy", "past, present and future activities", "social participation", "death and death", "intimacy".
A high score indicates a high quality of life.
|
Initially, 1st week
|
World Health Organization Quality of Life - Old Module
Time Frame: At 5th week
|
It consists of 24 items in six facets.
The facets of this module are "sensory abilities", "autonomy", "past, present and future activities", "social participation", "death and death", "intimacy".
A high score indicates a high quality of life.
|
At 5th week
|
World Health Organization Quality of Life - Old Module
Time Frame: Through study completion at 6th month
|
It consists of 24 items in six facets.
The facets of this module are "sensory abilities", "autonomy", "past, present and future activities", "social participation", "death and death", "intimacy".
A high score indicates a high quality of life.
|
Through study completion at 6th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: Initially, 1st week
|
It was designed to assess balance and determine fall risk in older adults (Berg et al, 1989).
It is a scale that includes 14 instructions and is scored between 0 and 4 by observing the performance of the person for each instruction.
The highest score is 56, 0-20 points indicate balance disorder, 21-40 points indicate that balance is maintained with assistance, and 41-56 points indicate the existence of a good balance
|
Initially, 1st week
|
Berg Balance Scale
Time Frame: At 5th week
|
It was designed to assess balance and determine fall risk in older adults (Berg et al, 1989).
It is a scale that includes 14 instructions and is scored between 0 and 4 by observing the performance of the person for each instruction.
The highest score is 56, 0-20 points indicate balance disorder, 21-40 points indicate that balance is maintained with assistance, and 41-56 points indicate the existence of a good balance
|
At 5th week
|
Berg Balance Scale
Time Frame: Through study completion at 6th month
|
It was designed to assess balance and determine fall risk in older adults (Berg et al, 1989).
It is a scale that includes 14 instructions and is scored between 0 and 4 by observing the performance of the person for each instruction.
The highest score is 56, 0-20 points indicate balance disorder, 21-40 points indicate that balance is maintained with assistance, and 41-56 points indicate the existence of a good balance
|
Through study completion at 6th month
|
International Fall Efficiency Scale
Time Frame: Initially, 1st week
|
: It is a patient-rated scale that determines the level of concerns about falling in activities. of daily living and the confidence to perform activities without fear of falling.
It was developed by Tinetti et al. in 1990.
The 16 questions in the scale were scored between 1-4.
Validity and reliability studies have been established
|
Initially, 1st week
|
International Fall Efficiency Scale
Time Frame: At 5th week
|
: It is a patient-rated scale that determines the level of concerns about falling in activities. of daily living and the confidence to perform activities without fear of falling.
It was developed by Tinetti et al. in 1990.
The 16 questions in the scale were scored between 1-4.
Validity and reliability studies have been established
|
At 5th week
|
International Fall Efficiency Scale
Time Frame: Through study completion at 6th month
|
: It is a patient-rated scale that determines the level of concerns about falling in activities. of daily living and the confidence to perform activities without fear of falling.
It was developed by Tinetti et al. in 1990.
The 16 questions in the scale were scored between 1-4.
Validity and reliability studies have been established
|
Through study completion at 6th month
|
Functional Independence Measurement
Time Frame: Initially, 1st week
|
FIM was developed in 1987 and it indicates the degree of independence of a person in activities of daily living.
The instrument includes 18 items under 6 subheadings: self-care, sphincter control, transfers, locomotion, communication, and social cognition.
Each item is scored at 7 levels, with 'level 1' representing full assistance and 'level 7' representing complete independence.
The total score is between 18-126.
|
Initially, 1st week
|
Functional Independence Measurement
Time Frame: At 5th week
|
FIM was developed in 1987 and it indicates the degree of independence of a person in activities of daily living.
The instrument includes 18 items under 6 subheadings: self-care, sphincter control, transfers, locomotion, communication, and social cognition.
Each item is scored at 7 levels, with 'level 1' representing full assistance and 'level 7' representing complete independence.
The total score is between 18-126.
|
At 5th week
|
Functional Independence Measurement
Time Frame: Through study completion at 6th month
|
FIM was developed in 1987 and it indicates the degree of independence of a person in activities of daily living.
The instrument includes 18 items under 6 subheadings: self-care, sphincter control, transfers, locomotion, communication, and social cognition.
Each item is scored at 7 levels, with 'level 1' representing full assistance and 'level 7' representing complete independence.
The total score is between 18-126.
|
Through study completion at 6th month
|
Dual Task Questionnaire
Time Frame: Initially, 1st week
|
: DTQ is used to provide information about the difficulties experienced in dual tasks related to daily living activities.
It is a short test consisting of 10 questions.
It has been used in patients with stroke and traumatic brain injury.
It consists of 5 answers and is scored between 0-4.
A score of "4" indicates that difficulties are experienced very often, and "0" indicates that there is no difficulty.
|
Initially, 1st week
|
Dual Task Questionnaire
Time Frame: At 5th week
|
: DTQ is used to provide information about the difficulties experienced in dual tasks related to daily living activities.
It is a short test consisting of 10 questions.
It has been used in patients with stroke and traumatic brain injury.
It consists of 5 answers and is scored between 0-4.
A score of "4" indicates that difficulties are experienced very often, and "0" indicates that there is no difficulty.
|
At 5th week
|
Dual Task Questionnaire
Time Frame: Through study completion at 6th month
|
: DTQ is used to provide information about the difficulties experienced in dual tasks related to daily living activities.
It is a short test consisting of 10 questions.
It has been used in patients with stroke and traumatic brain injury.
It consists of 5 answers and is scored between 0-4.
A score of "4" indicates that difficulties are experienced very often, and "0" indicates that there is no difficulty.
|
Through study completion at 6th month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HANDE USTA, PHD, Pamukkale University
Publications and helpful links
General Publications
- Bruce H, Lai L, Bherer L, Lussier M, St-Onge N, Li KZH. The effect of simultaneously and sequentially delivered cognitive and aerobic training on mobility among older adults with hearing loss. Gait Posture. 2019 Jan;67:262-268. doi: 10.1016/j.gaitpost.2018.10.020. Epub 2018 Oct 23.
- Bruce H, Aponte D, St-Onge N, Phillips N, Gagne JP, Li KZH. The Effects of Age and Hearing Loss on Dual-Task Balance and Listening. J Gerontol B Psychol Sci Soc Sci. 2019 Jan 10;74(2):275-283. doi: 10.1093/geronb/gbx047.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/1933.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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