NCT05190081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

November 6, 2021

Last Update Submit

September 28, 2023

Conditions

Keywords

Age Related Hearing LossDual TaskCognitive FunctionPhysical Function

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (12)

  • Berg Balance Scale

    Initially, 1st week

  • Berg Balance Scale

    At 5th week

  • Berg Balance Scale

    Through study completion at 6th month

  • International Fall Efficiency Scale

    Initially, 1st week

  • International Fall Efficiency Scale

    At 5th week

  • +7 more secondary outcomes

Study Arms (3)

single-task training group

EXPERIMENTAL

Tasks were completed separately in the single-task training group

Other: TASK TRAINING

dual-task training group

EXPERIMENTAL

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

Other: TASK TRAINING

control group

NO INTERVENTION

No intervention was performed in the control group

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. 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.

dual-task training groupsingle-task training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kinikli, 20070, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30390596BACKGROUND
  • 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.

    PMID: 28486677BACKGROUND

MeSH Terms

Conditions

Hearing LossPresbycusisVestibular Diseases

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, SensorineuralLabyrinth Diseases

Study Officials

  • HANDE USTA, PHD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Research Assisstant

Study Record Dates

First Submitted

November 6, 2021

First Posted

January 13, 2022

Study Start

January 1, 2019

Primary Completion

January 23, 2021

Study Completion

March 1, 2021

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations