Hearing LossNCT05190081
Task Training In Older Adults With Age-Related Hearing Loss
A study testing TASK TRAINING in people with Hearing Loss and Age Related Hearing Loss, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hearing Loss, Age Related Hearing Loss, Physical Disability
- What is being tested?
- TASK TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- TASK TRAINING
- Keywords
- Age Related Hearing Loss, Dual Task, Cognitive Function, Physical Function
- Medical subject headings
- Hearing Loss, Presbycusis, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASK TRAININGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| single-task training group | Experimental | Tasks were completed separately in the single-task training group Receives: Other: TASK TRAINING |
| dual-task training group | Experimental | Tasks were completed at the same time in the dual-task training group Receives: Other: TASK TRAINING |
| control group | No intervention | No intervention was performed in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion at 6th month
Secondary outcomes (12)
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
Measured: Initially, 1st week
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
Measured: At 5th week
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
Measured: Through study completion at 6th month
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
Measured: Initially, 1st week
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
Measured: At 5th week
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
Measured: Through study completion at 6th month
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.
Measured: Initially, 1st week
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.
Measured: At 5th week
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.
Measured: Through study completion at 6th month
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.
Measured: Initially, 1st week
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.
Measured: At 5th week
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.
Measured: Through study completion at 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2019
- Primary completion23 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
- Investigators
- HANDE USTA, PHD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190081
- Sponsor's protocol ID
- 60116787-020/1933.
- Status last verified
- Sep 2023
- First submitted
- 6 Nov 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30390596Bruce 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of the Effects Of Dual-Task And Single-Task Training In Older Adults With Age-Related Hearing Loss
- ClinicalTrials.gov ID
- NCT05190081
- Acronym / sponsor ID
- 60116787-020/1933.
- Keywords
- Age Related Hearing Loss, Dual Task, Cognitive Function, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| single-task training group | Experimental | Other: TASK TRAININGTasks were completed separately in the single-task training group |
| dual-task training group | Experimental | Other: TASK TRAININGTasks were completed at the same time in the dual-task training group |
| control group | No intervention | –No intervention was performed in the control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TASK TRAININGA 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. | Other | dual-task training group, single-task training group |
Primary outcome
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
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
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
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
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
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
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
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.
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.
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.
12 secondary outcomes
Berg Balance Scale
Time frame: Initially, 1st week
Berg Balance Scale
Time frame: At 5th week
Berg Balance Scale
Time frame: Through study completion at 6th month
International Fall Efficiency Scale
Time frame: Initially, 1st week
International Fall Efficiency Scale
Time frame: At 5th week
International Fall Efficiency Scale
Time frame: Through study completion at 6th month
Functional Independence Measurement
Time frame: Initially, 1st week
Functional Independence Measurement
Time frame: At 5th week
Functional Independence Measurement
Time frame: Through study completion at 6th month
Dual Task Questionnaire
Time frame: Initially, 1st week
Dual Task Questionnaire
Time frame: At 5th week
Dual Task Questionnaire
Time frame: Through study completion at 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 30390596Bruce 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.
- Background: PubMed 28486677Bruce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HANDE USTA, PHD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TASK TRAINING in people with Hearing Loss and Age Related Hearing Loss, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Senior Fitness Test (time frame: Initially, 1st week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190081, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.