Older AdultsNCT05914012
Telerehabilitation Based on Otago Exercises for Older Adults
A study testing Telerehabilitation based on Otago Exercise Program in people with Older Adults, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study is a single-blind, randomized controlled, prospective clinical trial. At least 62 older adults aged 65 and over were included in the study. Evaluations were made twice, before starting the study and after completion. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults
- What is being tested?
- Telerehabilitation based on Otago Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2021to 31 May 2023
- 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
- Sedentary and sedentary older adults who do not have any neurological, cognitive, or communication problems that may affect assessments, and who volunteer to participate in the study.
- Not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.
Who cannot join
- Participants who have communication problems, are younger than 65 years old, have any neurological diagnosis and have orthopedic, mental and communication problems that prevent evaluations, and do not consent to participate in the study.
- Those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Telerehabilitation Program Based on Otago Exercises on Balance, Frailty and Quality of Life in tOlder Adults: A Randomized-Controlled Study
This study is a single-blind, randomized controlled, prospective clinical trial. At least 62 older adults aged 65 and over were included in the study. Evaluations were made twice, before starting the study and after completion. Otago Exercise Program based on telerehabilitation was applied to the intervention group for a total of 21 sessions, 7 days a week for 3 weeks. The control group did not participate in any exercise program during the study period; however, it was reported that they could be included in the Otago Exercise Program at the end of the study.
Read the detailed description
Sociodemographic data and information about falling were recorded. Edmonton Frail Scale, Modified Fall Efficiency Scale, Five-Dimensional European Quality of Life Scale-5D-3L, Timed Up and Go Test, Four-Step Balance Test and 30 sec Sit to StandTest were applied to all older adults. Evaluations were applied at the beginning and end of the study. A total of 21 sessions of Otago Exercise Program were applied to the intervention group, 30 minutes/session, 7 days/week for 3 weeks. A printed physical activity recommendation brochure prepared for the older adults by the Ministry of Health of the Republic of Turkey was distributed to both groups. The older adults in the control group did not participate in any exercise program during the study period.
- Conditions
- Older Adults
- Being tested
- Telerehabilitation based on Otago Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation based on Otago Exercise ProgramOther
It took a total of 21 sessions, 7 days a week for 3 weeks. The sessions lasted 30 minutes. It is recommended to do exercises with comfortable shoes at least 1 hour after a meal. Each of his exercises will be videotaped and numbered and delivered to the intervention group via social networks and the Internet or by memory. In each exercise session, the physiotherapist followed the exercise sessions through social networks and answered questions from the older adults.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 125 older adults aged 65 and over, who do not have any neurological, cognitive and communication problems that may affect the evaluations, and who volunteer to participate in the study and who are sedentary. Receives: Other: Telerehabilitation based on Otago Exercise Program |
| Control Group | No intervention | 125 older adults not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Edmonton Frail Scale
The scale consists of nine areas of vulnerability, which are considered to be the determinants of vulnerability. Among these vulnerability areas, general health status and drug use are evaluated with two questions, and other areas with a single question. The scale consists of 11 items in total. Two areas of cognitive and functional performance are tested using performance-based items. Clock testing is used for cognitive status and timed up-and-go testing is used for functional performance. The test takes less than five minutes to administer. The minimum total score is zero and the maximum score is 17. An increase in the total score obtained from the scale indicates that the severity of vulnerability increases. fragility to scale; It consists of five levels: not fragile, sensitive, slightly fragile, moderately fragile, and severely fragile. The Turkish version of the scale was found to be valid and reliable.
Measured: 8 months
The Modified Falls Efficacy Scale
The Modified Fall Efficiency Scale is an expanded version of the Fall Efficiency Scale, which includes items questioning confidence during 4 different outdoor activities. The scale evaluates the sense of security related to activities of daily living (such as dressing, bathing, crossing) on a ten-point visual analog scale. 10 items of the scale are related to indoor activities and 4 items are related to outdoor activities. Items in the scale are scored between 0 (not confident) and 10 (completely sure) to assess the participants' self-efficacy regarding falling. The scale score is calculated by dividing the sum of the scores per question by the number of questions. A high score means a high sense of safety and competence against falling. The Turkish validity and reliability study of the questionnaire was conducted.
Measured: 8 months
The Five-Dimensional European Quality of Life Scale (EQ-5D-3L)
Consisting of five dimensions: movement, self-care, usual activities, pain/discomfort, and anxiety/depression, this scale was developed by the European Quality of Life Research Society (EuroQol) in 1990 to measure health-related quality of life. Each dimension of the scale is calculated over 3 points as no problem, some problem and major problem. In addition, individuals indicate their current health status by marking on a visual analog scale (0-100 points). The Turkish version was found to be valid and reliable.
Measured: 8 months
The Timed Up and Go Test
The Timed Get Up and Go Test was developed in 1991 by Podsiadlo and Richardson. For the test, the individual is asked to get up from a standard chair, walk 3 meters, return and sit back in the chair. The duration begins with the individual getting up from the chair and ends with sitting down. The result is recorded in seconds.
Measured: 8 months
The Four Step Balance Test
The test consists of four different tasks (feet together, semi-tandem, tandem, and standing on one leg) that become increasingly difficult in the standing position. After the patient regains his balance, the physiotherapist releases the support and the patient is asked to maintain the position. During this time, the time is kept and recorded in seconds. If the patient can hold the position for 10 seconds without moving his feet or needing support, the next position is passed.
Measured: 8 months
The 30 sec Sit to Stand Test
The patient sits in a chair with a standard sitting height and backrest. They cross their hands on their chest. The patient is asked to sit and stand up from the chair as quickly as possible. The number of sitting and getting up is noted by keeping a 30-second timer with a stopwatch.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start22 Dec 2021
- Primary completion1 Jul 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914012
- Sponsor's protocol ID
- E-60116787-020-136972
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Zhao L, Liu Y, Zhou Z, Zhang H, Wei D, Chen J, Li Y, Ou J, Huang J, Yang X, Ma C. Otago exercise programme for physical function and mental health among older adults with cognitive frailty during COVID-19: A randomised controlled trial. J Clin Nurs. 2025 Dec;34(12):5130-5143. doi: 10.1111/jocn.15964. Epub 2021 Jul 21.
PubMed 34289524Binns E, Taylor D. The effect of the Otago Exercise Programme on strength and balance in community dwelling older women. New Zealand Journal of Physiotherapy. 2011;39(2).
Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13. doi: 10.1177/1357633X15572201. Epub 2015 Feb 22.
PubMed 25712109
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation Program Based on Otago Exercises on Balance, Frailty and Quality of Life in tOlder Adults: A Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT05914012
- Acronym / sponsor ID
- E-60116787-020-136972
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 22 Jun 2023 (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 is a single-blind, randomized controlled, prospective clinical trial. At least 62 older adults aged 65 and over were included in the study. Evaluations were made twice, before starting the study and after completion. Otago Exercise Program based on telerehabilitation was applied to the intervention group for a total of 21 sessions, 7 days a week for 3 weeks. The control group did not participate in any exercise program during the study period; however, it was reported that they could be included in the Otago Exercise Program at the end of the study.
Detailed description
Sociodemographic data and information about falling were recorded. Edmonton Frail Scale, Modified Fall Efficiency Scale, Five-Dimensional European Quality of Life Scale-5D-3L, Timed Up and Go Test, Four-Step Balance Test and 30 sec Sit to StandTest were applied to all older adults. Evaluations were applied at the beginning and end of the study. A total of 21 sessions of Otago Exercise Program were applied to the intervention group, 30 minutes/session, 7 days/week for 3 weeks. A printed physical activity recommendation brochure prepared for the older adults by the Ministry of Health of the Republic of Turkey was distributed to both groups. The older adults in the control group did not participate in any exercise program during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Telerehabilitation based on Otago Exercise Program125 older adults aged 65 and over, who do not have any neurological, cognitive and communication problems that may affect the evaluations, and who volunteer to participate in the study and who are sedentary. |
| Control Group | No intervention | –125 older adults not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Sedentary and sedentary older adults who do not have any neurological, cognitive, or communication problems that may affect assessments, and who volunteer to participate in the study.
- Not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.
Key exclusion criteria (2 listed)
- Participants who have communication problems, are younger than 65 years old, have any neurological diagnosis and have orthopedic, mental and communication problems that prevent evaluations, and do not consent to participate in the study.
- Those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.
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 |
|---|---|---|
| Telerehabilitation based on Otago Exercise ProgramIt took a total of 21 sessions, 7 days a week for 3 weeks. The sessions lasted 30 minutes. It is recommended to do exercises with comfortable shoes at least 1 hour after a meal. Each of his exercises will be videotaped and numbered and delivered to the intervention group via social networks and the Internet or by memory. In each exercise session, the physiotherapist followed the exercise sessions through social networks and answered questions from the older adults. | Other | Intervention Group |
Primary outcome
The Edmonton Frail Scale
Time frame: 8 months
The scale consists of nine areas of vulnerability, which are considered to be the determinants of vulnerability. Among these vulnerability areas, general health status and drug use are evaluated with two questions, and other areas with a single question. The scale consists of 11 items in total. Two areas of cognitive and functional performance are tested using performance-based items. Clock testing is used for cognitive status and timed up-and-go testing is used for functional performance. The test takes less than five minutes to administer. The minimum total score is zero and the maximum score is 17. An increase in the total score obtained from the scale indicates that the severity of vulnerability increases. fragility to scale; It consists of five levels: not fragile, sensitive, slightly fragile, moderately fragile, and severely fragile. The Turkish version of the scale was found to be valid and reliable.
The Modified Falls Efficacy Scale
Time frame: 8 months
The Modified Fall Efficiency Scale is an expanded version of the Fall Efficiency Scale, which includes items questioning confidence during 4 different outdoor activities. The scale evaluates the sense of security related to activities of daily living (such as dressing, bathing, crossing) on a ten-point visual analog scale. 10 items of the scale are related to indoor activities and 4 items are related to outdoor activities. Items in the scale are scored between 0 (not confident) and 10 (completely sure) to assess the participants' self-efficacy regarding falling. The scale score is calculated by dividing the sum of the scores per question by the number of questions. A high score means a high sense of safety and competence against falling. The Turkish validity and reliability study of the questionnaire was conducted.
The Five-Dimensional European Quality of Life Scale (EQ-5D-3L)
Time frame: 8 months
Consisting of five dimensions: movement, self-care, usual activities, pain/discomfort, and anxiety/depression, this scale was developed by the European Quality of Life Research Society (EuroQol) in 1990 to measure health-related quality of life. Each dimension of the scale is calculated over 3 points as no problem, some problem and major problem. In addition, individuals indicate their current health status by marking on a visual analog scale (0-100 points). The Turkish version was found to be valid and reliable.
The Timed Up and Go Test
Time frame: 8 months
The Timed Get Up and Go Test was developed in 1991 by Podsiadlo and Richardson. For the test, the individual is asked to get up from a standard chair, walk 3 meters, return and sit back in the chair. The duration begins with the individual getting up from the chair and ends with sitting down. The result is recorded in seconds.
The Four Step Balance Test
Time frame: 8 months
The test consists of four different tasks (feet together, semi-tandem, tandem, and standing on one leg) that become increasingly difficult in the standing position. After the patient regains his balance, the physiotherapist releases the support and the patient is asked to maintain the position. During this time, the time is kept and recorded in seconds. If the patient can hold the position for 10 seconds without moving his feet or needing support, the next position is passed.
The 30 sec Sit to Stand Test
Time frame: 8 months
The patient sits in a chair with a standard sitting height and backrest. They cross their hands on their chest. The patient is asked to sit and stand up from the chair as quickly as possible. The number of sitting and getting up is noted by keeping a 30-second timer with a stopwatch.
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 22 Jun 2023.
- Results publication: PubMed 34289524Chen X, Zhao L, Liu Y, Zhou Z, Zhang H, Wei D, Chen J, Li Y, Ou J, Huang J, Yang X, Ma C. Otago exercise programme for physical function and mental health among older adults with cognitive frailty during COVID-19: A randomised controlled trial. J Clin Nurs. 2025 Dec;34(12):5130-5143. doi: 10.1111/jocn.15964. Epub 2021 Jul 21.
- Results publicationBinns E, Taylor D. The effect of the Otago Exercise Programme on strength and balance in community dwelling older women. New Zealand Journal of Physiotherapy. 2011;39(2).
- Results publication: PubMed 25712109Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13. doi: 10.1177/1357633X15572201. Epub 2015 Feb 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation based on Otago Exercise Program in people with Older Adults, 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 2 inclusion and 2 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 22 Jun 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?
The Edmonton Frail Scale (time frame: 8 months). The study lists 6 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 NCT05914012, which also lists 3 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 22 Jun 2023.