Age ProblemNCT03320668
Efficacy of the Otago Exercise Program Delivered as Group Training Versus Individually Tailored Training
A study testing Otago Exercise Program (OEP) in people with Age Problem, run by Instituto de Salud Carlos III at 9 sites in Spain.
Trial summary
A non-inferiority controlled clinical trial using randomization for allocation at the level of general practice in 21 centers (in 8 Spanish regions), to compare a group Otago exercise program (OEP) [delivered by specifically trained instructors and supplemented by prescriptive recommendations for home exercising]… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Problem
- What is being tested?
- Otago Exercise Program (OEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 9 sitesSpain
- Study dates
- 10 Jan 2017to 28 Feb 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects who belong (ascribed) to primary healthcare centers of the same health area, aged 65 to 80 years, non-institutionalized, independents for ambulation (the scores achieved from the first part of SPPB scale in relation of the balance will be different from zero in any position evaluated.) and provide their informed consent for participating in the study.
Who cannot join
- Subject such residential period in the Health Basic Area of the primary health center or it life expectancies has lower 9 months. in the health area of the primary healthcare center.
- Mild and moderate cognitive impairment (according to the diagnosis from medical history).
- Sight-impairment or hearing impairment which prevent to follow the intervention (according to the diagnosis from medical history).
- Absolute contraindication to perform physical exercise (according to the diagnosis from medical history)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Institut Català de la Salut (ICS)
Barcelona, Gran Via de Les Corts Catalanes, 587-589, 08004
Institut Català de la Salut
Barcelona, Gran Via de Les Corts Catalanes, 587-589, 08004
Universidad de Córdoba
Córdoba, Av. de Medina Azahara, 5, 14005
Servicio de Salud de Canarias
Las Palmas de Gran Canaria, Avenida Juan Xxiii,17, 35071
Servicio de Salud de Madrid
Madrid, Avenida Abrantes, 55, 28025
Servicio Murciano de Salud
Murcia, Calle Central, 7, Espinardo, 30100
Servicio de Salud del Principado de Asturias
Oviedo, Plaza Del Carbayón, Oviedo, 33001
Servei de Salut de Les Illes Balears
Palma de Mallorca, Carrer de La Reina Esclaramunda, 9, Palma, 07003
Osakidetza
Vitoria-Gasteiz, Araba Kalea, 45, Vitoria-Gasteiz, 01006
About this study
Official title: Efficacy of the Otago Exercise Program (OEP) Delivered as Group Training Versus Individually Tailored Training in Community-dwelling Adults Between 65 and 80 Years Old
A non-inferiority controlled clinical trial using randomization for allocation at the level of general practice in 21 centers (in 8 Spanish regions), to compare a group Otago exercise program (OEP) [delivered by specifically trained instructors and supplemented by prescriptive recommendations for home exercising], with an individual OEP [also delivered by specifically trained professionals and supplemented by prescriptive recommendations for home exercising], with twelve months follow-up to determine the effectiveness of the OEP in terms of prevention of falls in a community-dwelling 65- to 80-year-old population.
Read the detailed description
OBJECTIVES:
To compare the effectiveness of the Otago Exercise Program (OEP) delivered as group training versus individually tailored training in community-dwelling adults between 65 and 80 years old, on the probability of falls, improved functional balance and muscle strength and, quality of walk in the 12 months follow up.
To compare the effectiveness of both interventions to improve dynamic and static balance and gait quality in the same population.
DESIGN:
Non-inferiority clinical trial, multicentric, simple blind (blind analysis to prevent bias), with two interventions, implementation of group and individual OEP with random assign. The follow-up period will be twelve months after the OEP training.
FIELD OF STUDY:
21 Primary Health Centers (PHC) belonging to the National Health System in 8 different regions: Andalucía, Asturias, Islas Baleares, Canarias, Cataluña, Comunidad de Madrid, Región de Murcia and País Vasco
PARTICIPANTS:
Subjects who belong to primary care centers in the same health area, 65 to 80 years of age, who are not institutionalized, independent for walk (the score of the first part of the Short Physical Performance Battery scale (SPPB scale) in relation to balancing must be different from zero in any assessed position) and provide informed consent to participate in the study.
VARIABLES OF STUDY:
Principal Outcome: Percentage of falls (percentage of subjects falling)
Other Outcomes:
Safety of Intervention; Feasibility of interventions; Feasibility of the cascade training model based on the OEP; Economic analysis and added therapeutic value of both interventions.
DATA COLLECTION:
Subjects will be selected from the health centers through active recruitment by the health professionals.
The recruitment will be consecutive among the patients in the agenda in the days between 10 to 19 of each month from September 2017-December 2018.
Data will be collected at month 0, 6 and 12. Randomization will be performed by PHC and by subjects.
DATA ANALYSIS:
A descriptive analysis of sociodemographic and fall variables will be performed. The analysis to the comparative data between the two groups of the Randomize Clinical Trial will be done by protocol. In addition, an analysis will be made for the incidence density of falls, using Poisson regression models. For all a confidence level of 95% will be assumed, and the statistical software to be used to carry out the analysis will be Statistical Package for the Social Sciences version 22 (SPSS v22).
- Conditions
- Age Problem
- Being tested
- Otago Exercise Program (OEP)
- Keywords
- Falls Prevention, Otago Program, Community-Dwelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise Program (OEP)Other
Also called Usual Practice
A nurse/physiotherapist supported by an "instructor"-trained professional will give Otago Exercise Program (OEP) education to 10-people groups in 5 sessions (1st, 2nd, 4th and 8th week and one reinforcement session after 6 months). Telephone calls to participants will be made during non-training months (following a predefined telephonic interview protocol) to follow up. The OEP reduces the number of falls and fall-related injuries, improving balance and strength, confidence in performing everyday activities without falling. Whilst it has been shown to be effective in 4 controlled trials in New Zealand, it has not been tested in a primary care setting in Spain for feasibility, impact, acceptability and cost-effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| Individual OEP | No intervention | Randomized subjects (65 to 80-year-old) receiving individual Otago Exercise Program (OEP) training in a total of nine Primary Care Centers. An "OEP leader" trained nurse/physiotherapist will perform in its community consult individual education to each participant in five sessions: In the 1st, 2nd, 4th and 8th week and one reinforcement session after six months. A telephone call to each participant (following a predefined telephonic interview protocol) will be carried out in the months without training session to perform the follow-up. |
| Group OEP | Experimental | 65-80 year-old randomized subjects receiving group Otago Exercise Program (OEP) training in a total of nine Primary Care Centers. Receives: Other: Otago Exercise Program (OEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of falls
The participant will be provided with a notebook which should be completed each month. In the case a fall occur, the patient will be asked to fill the following items regarding the fall characteristics: Data, place, context in which the fall happened, consequences and attention required.
Measured: 12 months
Secondary outcomes (3)
Adverse events
- Adverse events during the intervention related to exclusion criteria (indication for a subject to leave the project)
- Adverse effects which can be directly or potentially associated with Otago exercises. For that, it will be established an external committee which will classify the adverse event among related, potentially related and none related with Otago exercise execution.
Measured: 12 months
Adherence
Adherence level to exercise program will be measured following the Exercise Adherence Rating Scale (EARS) through self-declared falls diary.
The EARS questionnaire is composed of 6 items, each of them is scaled from 0 (minimum) to 4 (maximum score). Total score is the sum of the 6 items, so that it ranges from a minimum score of 0 and a maximum score of 64.
Adherence measurements will be collected at 6 and 12 months.
Measured: 12 months
Participant satisfaction
Participant satisfaction with the intervention will be measured through "ad hoc" survey which include the following items:
4.1. Received information about exercise program and its benefits 4.2. Received Training about Otago Exercise Program 4.3. Assessment of Material 4.4. Teaching skills of your OEP trainer 4.5. Receptiveness of your health care professional to solve your doubts about the OEP 4.6. Global satisfaction with Otago Exercise Program
Each item will be scaled from 0 (Totally unsatisfied) to 4 (Very satisfied).
Total minimum and maximum scores are 0 and 64, respectively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start10 Jan 2017
- Primary completion30 Dec 2021
- Study completion28 Feb 2022
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 Age ProblemStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority clinical trial, multicentric, simple blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Collaborators
- Fondo de Investigacion Sanitaria, Osakidetza, MurciaSalud
- Responsible party
- Principal investigator, Teresa Moreno Casbas, Instituto de Salud Carlos III
- Investigators
- Teresa Moreno-Cascas, Doctor, Study director, Instituto de Salud Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320668
- Sponsor's protocol ID
- PI16CIII/00031
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2017
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albornos-Munoz L, Blanco-Blanco J, Cidoncha-Moreno MA, Abad-Corpa E, Rivera-Alvarez A, Lopez-Pisa RM, Caperos JM; Otago Project Working Group Consortium; Moreno-Casbas MT. Efficacy of the Otago-Exercise-Programme to reduce falls in community-dwelling adults aged 65-80 when delivered as group or individual training: Non-inferiority-clinical-trial. BMC Nurs. 2024 Oct 1;23(1):705. doi: 10.1186/s12912-024-02310-3.
PubMed 39354514Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.
PubMed 34999543
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Otago Exercise Program (OEP) Delivered as Group Training Versus Individually Tailored Training in Community-dwelling Adults Between 65 and 80 Years Old
- ClinicalTrials.gov ID
- NCT03320668
- Acronym / sponsor ID
- PI16CIII/00031
- Conditions
- Age Problem
- Keywords
- Falls Prevention, Otago Program, Community-Dwelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Collaborators
- Fondo de Investigacion Sanitaria, Osakidetza, MurciaSalud
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Oct 2017 (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.
A non-inferiority controlled clinical trial using randomization for allocation at the level of general practice in 21 centers (in 8 Spanish regions), to compare a group Otago exercise program (OEP) [delivered by specifically trained instructors and supplemented by prescriptive recommendations for home exercising], with an individual OEP [also delivered by specifically trained professionals and supplemented by prescriptive recommendations for home exercising], with twelve months follow-up to determine the effectiveness of the OEP in terms of prevention of falls in a community-dwelling 65- to 80-year-old population.
Detailed description
OBJECTIVES:
To compare the effectiveness of the Otago Exercise Program (OEP) delivered as group training versus individually tailored training in community-dwelling adults between 65 and 80 years old, on the probability of falls, improved functional balance and muscle strength and, quality of walk in the 12 months follow up.
To compare the effectiveness of both interventions to improve dynamic and static balance and gait quality in the same population.
DESIGN:
Non-inferiority clinical trial, multicentric, simple blind (blind analysis to prevent bias), with two interventions, implementation of group and individual OEP with random assign. The follow-up period will be twelve months after the OEP training.
FIELD OF STUDY:
21 Primary Health Centers (PHC) belonging to the National Health System in 8 different regions: Andalucía, Asturias, Islas Baleares, Canarias, Cataluña, Comunidad de Madrid, Región de Murcia and País Vasco
PARTICIPANTS:
Subjects who belong to primary care centers in the same health area, 65 to 80 years of age, who are not institutionalized, independent for walk (the score of the first part of the Short Physical Performance Battery scale (SPPB scale) in relation to balancing must be different from zero in any assessed position) and provide informed consent to participate in the study.
VARIABLES OF STUDY:
Principal Outcome: Percentage of falls (percentage of subjects falling)
Other Outcomes:
Safety of Intervention; Feasibility of interventions; Feasibility of the cascade training model based on the OEP; Economic analysis and added therapeutic value of both interventions.
DATA COLLECTION:
Subjects will be selected from the health centers through active recruitment by the health professionals.
The recruitment will be consecutive among the patients in the agenda in the days between 10 to 19 of each month from September 2017-December 2018.
Data will be collected at month 0, 6 and 12. Randomization will be performed by PHC and by subjects.
DATA ANALYSIS:
A descriptive analysis of sociodemographic and fall variables will be performed. The analysis to the comparative data between the two groups of the Randomize Clinical Trial will be done by protocol. In addition, an analysis will be made for the incidence density of falls, using Poisson regression models. For all a confidence level of 95% will be assumed, and the statistical software to be used to carry out the analysis will be Statistical Package for the Social Sciences version 22 (SPSS v22).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority clinical trial, multicentric, simple blind
| Arm | Type | Receives |
|---|---|---|
| Individual OEP | No intervention | –Randomized subjects (65 to 80-year-old) receiving individual Otago Exercise Program (OEP) training in a total of nine Primary Care Centers. An "OEP leader" trained nurse/physiotherapist will perform in its community consult individual education to each participant in five sessions: In the 1st, 2nd, 4th and 8th week and one reinforcement session after six months. A telephone call to each participant (following a predefined telephonic interview protocol) will be carried out in the months without training session to perform the follow-up. |
| Group OEP | Experimental | Other: Otago Exercise Program (OEP)65-80 year-old randomized subjects receiving group Otago Exercise Program (OEP) training in a total of nine Primary Care Centers. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects who belong (ascribed) to primary healthcare centers of the same health area, aged 65 to 80 years, non-institutionalized, independents for ambulation (the scores achieved from the first part of SPPB scale in relation of the balance will be different from zero in any position evaluated.) and provide their informed consent for participating in the study.
Key exclusion criteria (4 listed)
- Subject such residential period in the Health Basic Area of the primary health center or it life expectancies has lower 9 months. in the health area of the primary healthcare center.
- Mild and moderate cognitive impairment (according to the diagnosis from medical history).
- Sight-impairment or hearing impairment which prevent to follow the intervention (according to the diagnosis from medical history).
- Absolute contraindication to perform physical exercise (according to the diagnosis from medical history)
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 Program (OEP)Also: Usual PracticeA nurse/physiotherapist supported by an "instructor"-trained professional will give Otago Exercise Program (OEP) education to 10-people groups in 5 sessions (1st, 2nd, 4th and 8th week and one reinforcement session after 6 months). Telephone calls to participants will be made during non-training months (following a predefined telephonic interview protocol) to follow up. The OEP reduces the number of falls and fall-related injuries, improving balance and strength, confidence in performing everyday activities without falling. Whilst it has been shown to be effective in 4 controlled trials in New Zealand, it has not been tested in a primary care setting in Spain for feasibility, impact, acceptability and cost-effectiveness. | Other | Group OEP |
Primary outcome
Percentage of falls
Time frame: 12 months
The participant will be provided with a notebook which should be completed each month. In the case a fall occur, the patient will be asked to fill the following items regarding the fall characteristics: Data, place, context in which the fall happened, consequences and attention required.
3 secondary outcomes
Adverse events
Time frame: 12 months
Adherence
Time frame: 12 months
Participant satisfaction
Time frame: 12 months
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 3 Aug 2022.
- Derived from this study: PubMed 39354514Albornos-Munoz L, Blanco-Blanco J, Cidoncha-Moreno MA, Abad-Corpa E, Rivera-Alvarez A, Lopez-Pisa RM, Caperos JM; Otago Project Working Group Consortium; Moreno-Casbas MT. Efficacy of the Otago-Exercise-Programme to reduce falls in community-dwelling adults aged 65-80 when delivered as group or individual training: Non-inferiority-clinical-trial. BMC Nurs. 2024 Oct 1;23(1):705. doi: 10.1186/s12912-024-02310-3.
- Derived from this study: PubMed 34999543Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.
- 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.
Teresa Moreno-Cascas, Doctor study director
Instituto de Salud Carlos III
9 sites 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 (OEP) in people with Age Problem, run by Instituto de Salud Carlos III at 9 sites in Spain.
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 1 inclusion and 4 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
Percentage of falls (time frame: 12 months). 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 NCT03320668, 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 3 Aug 2022.