Older AdultsNCT05002803
The Development and Validation of the Arabic Otago Exercise Program
A study testing Otago Exercise Program in people with Older Adults, run by University of Jordan at 1 site in Jordan.
Trial summary
Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Otago Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 4 Aug 2021to 31 Dec 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who are 60 years of age and older.
- Who can read and write in Arabic language.
- Who are able to walk outdoors with no more support than a single point cane.
Who cannot join
- Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe arthritis of a lower limb) or major neurological disorder (e.g., stroke with unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could restrict functional mobility.
- Who are unable to comprehend study information and consent processes due to any illness including dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Controlled Study
Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises.
The OEP is available in English language since late 1990. However, its use in the Arabic-speaking countries is limited due to the language barrier. Therefore, translating such a program to the Arabic language would facilitate its use among Arabic-speaking older adults.
Read more
Therefore, this study aims:
- To translate the Otago Exercise Program (OEP) into the Arabic language.
- To assess the feasibility of the Arabic OEP in a pilot sample of Arabic-speaking older adults.
Read the detailed description
- Research ethics: This study got the ethics approval from the IRB at Jordan University Hospital at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all participants. To insure the privacy of participants, every older adult will be assigned a study identification number. All results will be stored in a locked cabinet/computer only accessible by the researchers.
- Participants: Data will be collected prospectively from older adults in Jordan. Older adults will be approached to complete the program via Jordan University Hospital, community based organizations (e.g. Help-Age International Jordan) and social media platforms such as Facebook and WhatsApp.
Design:
Phase 1: Translation and cultural adaptation of the Otago Exercise Program (OEP) into the Arabic language.
- The permission of translating the program will be granted from its developers.
- English version of the program will be translated into the Arabic language in accordance with the World Health Organization (WHO) forward/backward translation protocol (https://www.who.int/substance_abuse/research_tools/translation/en/ ).
- An Arabic booklet of the OEP will be prepared.
Phase 2: Assessing feasibility of the OEP on a pilot sample of Arabic-speaking older adults using a focus group and a pilot Trial.
- The Arabic version of the OEP will be sent to an expert panel for review. Suggested changes will be considered and made.
- The Arabic version of the OEP will be sent to 2 groups that consist of 5 older adults each. They will be given sufficient time to go through the exercise manual before being invited to a focus group meeting to discuss the Arabic wording and feasibility of the Arabic version of the OEP.
- A topic guide will be prepared to assess the feasibility and user-friendliness of the Arabic OEP manual.
- The meeting will be recorded after taking their permission and the recording will be transcribed and analyzed.
- If there are major changes to the program, the experts will meet to make the appropriate changes and another focus group will be conducted.
- The final version of the Arabic OEP will be implemented for 8 weeks on a pilot sample of Arabic speaking older adults using a controlled design with 10 older adults in the treatment group and 10 older adults in the control group.
- Conditions
- Older Adults
- Being tested
- Otago Exercise Program
- Keywords
- Otago Exercise Program, Falls, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramOther
A Home-based Exercise Program to improve strength and balance and prevent falls.
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program | Experimental | Older adults will receive the Arabic Otago Exercise Program for 8 weeks plus health awareness videos. Receives: Other: Otago Exercise Program |
| Control group | No intervention | Older adults will receive only health awareness videos every 2 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Falls in the previous 12 months
Incidence of Falls and Falls Circumstances in the previous 12 months
Measured: Previous 12 months
Incidence of falls during the treatment period (8 weeks)
Incidence of falls during the treatment period (previous 2 months) to assess the effect of the intervention on the incidence of falls.
Measured: Immediately post intervention.
Secondary outcomes (8)
Fear of Falling (using the Falls Efficacy Scale-International)
The effect of the intervention on fear of falling. The total score ranges between 16 and 64 with a higher score indicates greater fear of falling (worse).
Measured: Immediately post intervention.
Balance (using Chair balance test and Four test balance scale)
The effect of the intervention on balance. The time taken to conduct these balance tasks are timed using a stopwatch. The longer the time taken by the participant to perform the tasks, the worse the balance. There is no minimum or maximum scores for these tests.
Measured: Immediately post intervention.
Mobility (using Timed-Up and go)
The effect of the intervention on mobility. This assessments of mobility is timed out using a stopwatch.
Measured: Immediately post intervention.
Grip strength (using a hand held dynamometer)
The effect of the intervention on grip strength. The strength of Hand grip muscle will be assessed using a dynamometer in kilograms.
Measured: Immediately post intervention.
The Quality of Life (using Medical Outcomes Study Short Form 12)
The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).
Measured: Immediately post intervention.
The severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)
The effect of the intervention on the severity of Anxiety and Depression. The total score for each subscale of the HADS ranges from 0 to 21 with higher score indicates more severe anxiety or depression (worse).
Measured: Immediately post intervention.
Pain (using pain rating scale)
The effect of the intervention on pain. The total score of PRS ranges between 0 to 10 with higher score indicates more pain and interference with discomfort (worse).
Measured: Immediately post intervention.
The severity of fatigue (using the Modified Fatigue Impact Scale)
The effect of the intervention on fatigue. The total score of MFIS ranges between 0 to 84 with higher score indicates higher impact of fatigue on on daily functioning (worse).
Measured: Immediately post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start4 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia A. Alghwiri, University of Jordan
- Investigators
- Alia A. Alghwiri, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002803
- Sponsor's protocol ID
- 2021/134
- Status last verified
- Apr 2023
- First submitted
- 4 Aug 2021
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Controlled Study
- ClinicalTrials.gov ID
- NCT05002803
- Acronym / sponsor ID
- 2021/134
- Conditions
- Older Adults
- Keywords
- Otago Exercise Program, Falls, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Aug 2021 (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.
Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises.
The OEP is available in English language since late 1990. However, its use in the Arabic-speaking countries is limited due to the language barrier. Therefore, translating such a program to the Arabic language would facilitate its use among Arabic-speaking older adults.
Therefore, this study aims:
- To translate the Otago Exercise Program (OEP) into the Arabic language.
- To assess the feasibility of the Arabic OEP in a pilot sample of Arabic-speaking older adults.
Detailed description
- Research ethics: This study got the ethics approval from the IRB at Jordan University Hospital at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all participants. To insure the privacy of participants, every older adult will be assigned a study identification number. All results will be stored in a locked cabinet/computer only accessible by the researchers.
- Participants: Data will be collected prospectively from older adults in Jordan. Older adults will be approached to complete the program via Jordan University Hospital, community based organizations (e.g. Help-Age International Jordan) and social media platforms such as Facebook and WhatsApp.
Design:
Phase 1: Translation and cultural adaptation of the Otago Exercise Program (OEP) into the Arabic language.
- The permission of translating the program will be granted from its developers.
- English version of the program will be translated into the Arabic language in accordance with the World Health Organization (WHO) forward/backward translation protocol (https://www.who.int/substance_abuse/research_tools/translation/en/ ).
- An Arabic booklet of the OEP will be prepared.
Phase 2: Assessing feasibility of the OEP on a pilot sample of Arabic-speaking older adults using a focus group and a pilot Trial.
- The Arabic version of the OEP will be sent to an expert panel for review. Suggested changes will be considered and made.
- The Arabic version of the OEP will be sent to 2 groups that consist of 5 older adults each. They will be given sufficient time to go through the exercise manual before being invited to a focus group meeting to discuss the Arabic wording and feasibility of the Arabic version of the OEP.
- A topic guide will be prepared to assess the feasibility and user-friendliness of the Arabic OEP manual.
- The meeting will be recorded after taking their permission and the recording will be transcribed and analyzed.
- If there are major changes to the program, the experts will meet to make the appropriate changes and another focus group will be conducted.
- The final version of the Arabic OEP will be implemented for 8 weeks on a pilot sample of Arabic speaking older adults using a controlled design with 10 older adults in the treatment group and 10 older adults in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program | Experimental | Other: Otago Exercise ProgramOlder adults will receive the Arabic Otago Exercise Program for 8 weeks plus health awareness videos. |
| Control group | No intervention | –Older adults will receive only health awareness videos every 2 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults who are 60 years of age and older.
- Who can read and write in Arabic language.
- Who are able to walk outdoors with no more support than a single point cane.
Key exclusion criteria (2 listed)
- Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe arthritis of a lower limb) or major neurological disorder (e.g., stroke with unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could restrict functional mobility.
- Who are unable to comprehend study information and consent processes due to any illness including dementia.
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 |
|---|---|---|
| Otago Exercise ProgramA Home-based Exercise Program to improve strength and balance and prevent falls. | Other | Otago Exercise Program |
Primary outcome
Incidence of Falls in the previous 12 months
Time frame: Previous 12 months
Incidence of Falls and Falls Circumstances in the previous 12 months
Incidence of falls during the treatment period (8 weeks)
Time frame: Immediately post intervention.
Incidence of falls during the treatment period (previous 2 months) to assess the effect of the intervention on the incidence of falls.
8 secondary outcomes
Fear of Falling (using the Falls Efficacy Scale-International)
Time frame: Immediately post intervention.
Balance (using Chair balance test and Four test balance scale)
Time frame: Immediately post intervention.
Mobility (using Timed-Up and go)
Time frame: Immediately post intervention.
Grip strength (using a hand held dynamometer)
Time frame: Immediately post intervention.
The Quality of Life (using Medical Outcomes Study Short Form 12)
Time frame: Immediately post intervention.
The severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)
Time frame: Immediately post intervention.
Pain (using pain rating scale)
Time frame: Immediately post intervention.
The severity of fatigue (using the Modified Fatigue Impact Scale)
Time frame: Immediately post intervention.
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 7 Apr 2023.
- 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.
Alia A. Alghwiri, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program in people with Older Adults, run by University of Jordan at 1 site in Jordan.
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 3 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 7 Apr 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 Jordan. 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?
Incidence of Falls in the previous 12 months (time frame: Previous 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023.