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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05190081
Other study ID # 60116787-020/1933.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date March 1, 2021

Study information

Verified date September 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 1, 2021
Est. primary completion date January 23, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Other:
TASK 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.

Locations

Country Name City State
Turkey Pamukkale University Denizli Kinikli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Initially, 1st week
Primary 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 At 5th week
Primary 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 Through study completion at 6th month
Primary 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 Initially, 1st week
Primary 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 At 5th week
Primary 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 Through study completion at 6th month
Primary 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 Initially, 1st week
Primary 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. Initially, 1st week
Primary 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. At 5th week
Primary 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. Through study completion at 6th month
Secondary 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 Initially, 1st week
Secondary 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 At 5th week
Secondary 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 Through study completion at 6th month
Secondary 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 Initially, 1st week
Secondary 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 At 5th week
Secondary 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 Through study completion at 6th month
Secondary 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. Initially, 1st week
Secondary 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. At 5th week
Secondary 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. Through study completion at 6th month
Secondary 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. Initially, 1st week
Secondary 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. At 5th week
Secondary 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. Through study completion at 6th month
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