Task Training In Older Adults With Age-Related Hearing Loss
Primary Purpose
Hearing Loss, Age Related Hearing Loss, Physical Disability
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TASK TRAINING
Sponsored by
About this trial
This is an interventional health services research trial for Hearing Loss focused on measuring Age Related Hearing Loss, Dual Task, Cognitive Function, Physical Function
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
single-task training group
dual-task training group
control group
Arm Description
Tasks were completed separately in the single-task training group
Tasks were completed at the same time in the dual-task training group
No intervention was performed in the control group
Outcomes
Primary Outcome Measures
Senior Fitness Test
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
Senior Fitness Test
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
Senior Fitness Test
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
Montreal Cognitive Assessment
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
Montreal Cognitive Assessment
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
Montreal Cognitive Assessment
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
Pure tone audiometry
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
World Health Organization Quality of Life - Old Module
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.
World Health Organization Quality of Life - Old Module
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.
World Health Organization Quality of Life - Old Module
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.
Secondary Outcome Measures
Berg Balance Scale
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
Berg Balance Scale
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
Berg Balance Scale
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
International Fall Efficiency Scale
: 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
International Fall Efficiency Scale
: 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
International Fall Efficiency Scale
: 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
Functional Independence Measurement
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.
Functional Independence Measurement
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.
Functional Independence Measurement
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.
Dual Task Questionnaire
: 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.
Dual Task Questionnaire
: 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.
Dual Task Questionnaire
: 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.
Full Information
NCT ID
NCT05190081
First Posted
November 6, 2021
Last Updated
September 28, 2023
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT05190081
Brief Title
Task Training In Older Adults With Age-Related Hearing Loss
Official Title
Investigation Of the Effects Of Dual-Task And Single-Task Training In Older Adults With Age-Related Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 23, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Age Related Hearing Loss, Physical Disability, Vestibular Disease
Keywords
Age Related Hearing Loss, Dual Task, Cognitive Function, Physical Function
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention groups were formed as single-task training, dual-task training, and control group. Distribution was made into groups using a simple randomized number selection technique.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-task training group
Arm Type
Experimental
Arm Description
Tasks were completed separately in the single-task training group
Arm Title
dual-task training group
Arm Type
Experimental
Arm Description
Tasks were completed at the same time in the dual-task training group
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention was performed in the control group
Intervention Type
Other
Intervention Name(s)
TASK TRAINING
Intervention Description
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.
Primary Outcome Measure Information:
Title
Senior Fitness Test
Description
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
Time Frame
Initially, 1st week
Title
Senior Fitness Test
Description
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
Time Frame
At 5th week
Title
Senior Fitness Test
Description
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
Time Frame
Through study completion at 6th month
Title
Montreal Cognitive Assessment
Description
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
Time Frame
Initially, 1st week
Title
Montreal Cognitive Assessment
Description
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
Time Frame
At 5th week
Title
Montreal Cognitive Assessment
Description
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
Time Frame
Through study completion at 6th month
Title
Pure tone audiometry
Description
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
Time Frame
Initially, 1st week
Title
World Health Organization Quality of Life - Old Module
Description
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.
Time Frame
Initially, 1st week
Title
World Health Organization Quality of Life - Old Module
Description
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.
Time Frame
At 5th week
Title
World Health Organization Quality of Life - Old Module
Description
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.
Time Frame
Through study completion at 6th month
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
Initially, 1st week
Title
Berg Balance Scale
Description
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
Time Frame
At 5th week
Title
Berg Balance Scale
Description
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
Time Frame
Through study completion at 6th month
Title
International Fall Efficiency Scale
Description
: 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
Time Frame
Initially, 1st week
Title
International Fall Efficiency Scale
Description
: 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
Time Frame
At 5th week
Title
International Fall Efficiency Scale
Description
: 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
Time Frame
Through study completion at 6th month
Title
Functional Independence Measurement
Description
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.
Time Frame
Initially, 1st week
Title
Functional Independence Measurement
Description
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.
Time Frame
At 5th week
Title
Functional Independence Measurement
Description
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.
Time Frame
Through study completion at 6th month
Title
Dual Task Questionnaire
Description
: 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.
Time Frame
Initially, 1st week
Title
Dual Task Questionnaire
Description
: 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.
Time Frame
At 5th week
Title
Dual Task Questionnaire
Description
: 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.
Time Frame
Through study completion at 6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HANDE USTA, PHD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Kinikli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30390596
Citation
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.
Results Reference
background
PubMed Identifier
28486677
Citation
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.
Results Reference
background
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Task Training In Older Adults With Age-Related Hearing Loss
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