ClinicalTrials.gg
CompletedNCT05190081Updated Sep 29, 2023

Task Training In Older Adults With Age-Related Hearing Loss

An interventional study of TASK TRAINING in Hearing Loss, Age Related Hearing Loss and Physical Disability, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Pamukkale University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2019, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hearing Loss
  • Age Related Hearing Loss
  • Physical Disability
  • Vestibular Disease

Keywords

  • Age Related Hearing Loss
  • Dual Task
  • Cognitive Function
  • Physical Function
03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's enrollment of 43 is close to the median of 44 across 561 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Pamukkale University is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being >65 years old
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    single-task training group

    Tasks were completed separately in the single-task training group

    Other: TASK TRAINING

  • Experimental
    dual-task training group

    Tasks were completed at the same time in the dual-task training group

    Other: TASK TRAINING

  • No intervention
    control group

    No intervention was performed in the control group

Interventions

  • OtherTASK TRAINING

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Initially, 1st week

  2. 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

    Time frame: At 5th week

  3. 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

    Time frame: Through study completion at 6th month

  4. 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

    Time frame: Initially, 1st week

  5. 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

    Time frame: At 5th week

  6. 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

    Time frame: Through study completion at 6th month

  7. 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

    Time frame: Initially, 1st week

  8. 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.

    Time frame: Initially, 1st week

  9. 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.

    Time frame: At 5th week

  10. 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.

    Time frame: Through study completion at 6th month

Secondary outcomes

  1. 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

    Time frame: Initially, 1st week

  2. 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

    Time frame: At 5th week

  3. 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

    Time frame: Through study completion at 6th month

  4. 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

    Time frame: Initially, 1st week

  5. 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

    Time frame: At 5th week

  6. 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

    Time frame: Through study completion at 6th month

  7. 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.

    Time frame: Initially, 1st week

  8. 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.

    Time frame: At 5th week

  9. 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.

    Time frame: Through study completion at 6th month

  10. 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.

    Time frame: Initially, 1st week

  11. 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.

    Time frame: At 5th week

  12. 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.

    Time frame: Through study completion at 6th month

07

Study locations

1 site
  • Pamukkale University
    Denizli, Kinikli 20070, Turkey
08

References and documents

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. PubMed 30390596 ↗
  • 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. PubMed 28486677 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jan 2021, 24 months.

Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's 24 months is below that.

Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2021
First posted
Jan 13, 2022
StartActual
Jan 1, 2019
Primary completionActual
Jan 23, 2021
CompletionActual
Mar 1, 2021
Last update
Sep 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05190081
Responsible party
HANDE USTA (Doctor, Research Assisstant, Pamukkale University) — Principal investigator
First posted
Jan 13, 2022
Start date
Jan 1, 2019
Primary completion
Jan 23, 2021
Completion
Mar 1, 2021
Last update
Sep 29, 2023

Study contacts

HANDE USTA, PHD
principal investigator · Pamukkale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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