AgingOAMTNCT05957133
Effect of Action Observation Training in Older Adults.
A study testing Multicomponent exercise without action observation. and Multicomponent exercise associated with action observation in people with Aging and Exercise, run by University of Salamanca.
Trial summary
Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Multicomponent exercise without action observation. and Multicomponent exercise associated with action observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2023to 30 Mar 2024
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- adults over 65 years of age.
Who cannot join
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
- Uncontrolled systemic and inflammatory pathologies
Show all 10Show fewer
- Congenital collagen compromise
- Presence of difficulties in performing the Initial Evaluation tests
- Language barriers
- Pending litigation or legal claim
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effect on Functionality of Multicomponent Training With and Without Action Observation in Older Adults.
Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. At the beginning and at the end of the programme, data were collected on participants' balance, fall risk and other parameters, using anthropometric tests (weight, % body fat and body mass index (BMI)), and physical performance tests (grip strength, the Short Physical Performance Battery, TUG and the stair step test). Study participants performed three 50-minute sessions per week for a total of 35 weeks. The components of balance, gait, cardiovascular resistance, stability, upper and lower limb strength, flexibility and breathing exercises were worked on. In the OC group, the physiotherapist performed the entire session together with the participants, while in the other group, the physiotherapist simply ordered the exercises.
Read the detailed description
Design: Randomised, controlled clinical trial with two parallel groups, in which adults over 65 years of age will be recruited. Study participants will be assigned to one of the two interventions. The study will have a duration of 35 weeks. There will be 2 evaluation visits, one initial, one final. During the intervention period there will be 3 weekly sessions of 50 minutes.
Scope: The study will be carried out in the Health Area of Salamanca, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multicomponent Exercise Group (GEM); 2) Multicomponent Exercise and Action Observation Group (GOA). The GEM and GOA sessions follow the same design, according to the recommendations of the American College of Sports Medicine (ACSM), the only difference being that in the GOA the physiotherapist will perform all the exercises with the participants.
Study population: Adults over 65 years of age from the city of Salamanca will be included, distributed in 2 groups in a 1:1 ratio. Randomisation will be performed using the Epidat 4.2 programme. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Functionality (Timed Up \& Go test (TUG), chair stand test (CS), hand grip test (HG) and Short Physical Performance Battery (SPPB)), gait speed (GS). stair step test; and body composition (% body fat, body weight, body mass index (BMI)).
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric Student's t-test will be used, and if they are non-parametric the Wilcoxon test will be used. An alpha risk of 0.05 is established as the limit of statistical significance. The statistical programme to be used will be SPSS, v.26.0.
The study will be carried out with the authorisation of the Ethics Committee for Research with Medicines (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. Participants will be informed of the objectives of the project and of the risks and benefits of the tests and interventions to be performed. The study has been designed and subsequently evaluated in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research on human beings, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
- Being tested
- Multicomponent exercise without action observation., Multicomponent exercise associated with action observation
- Keywords
- exercise, elderly, multicomponent exercise, Action Observation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise without action observation.Procedure or surgery
Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.
Multicomponent exercise associated with action observationProcedure or surgery
Different exercise modalities are integrated: aerobic, mobility, strength, balance and coordination exercises carried out at all times by the physiotherapist and observed by the participants.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise group without action observation (MTG) | Active comparator | The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc.
The progression of the different models is as follows:
E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work.
E. Strength: Increase sets, repetitions and decrease rest time. Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc.
Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making. Receives: Procedure: Multicomponent exercise without action observation. |
| Multicomponent exercise group associated to action observation (AOG) | Experimental | It is the same intervention as the other group with the addition of the observation of actions thanks to the fact that the physiotherapist carries out the exercises with them at all times.
The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc.
The progression of the exercises will be the same as in the other group. Receives: Procedure: Multicomponent exercise associated with action observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
Measured: thirty-five weeks
Secondary outcomes (7)
Gait speed
It is considered a fast, safe and very reliable test, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
Measured: thirty-five weeks
Timed Up and Go (TUG)
A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
Measured: thirty-five weeks
Grip strength test
Accurate measurement of hand grip strength requires the use of a calibrated hand dynamometer (Jamar Plus) under well-defined (standardised) test conditions. Force values below 16 kg are considered positive and indicate weakness.
Measured: thirty-five weeks
Chair stand test
It can be used as an indicator of lower limb muscle strength. It measures the time it takes a patient to stand up five times from a seated position without using the arms. Times greater than 15 seconds are considered positive and indicate weakness.
Measured: thirty-five weeks
Step-Up Box Test
Consists of climbing for two minutes on a 35 cm box as many times as possible. it trains the strength of the lower brain but also the cardiovascular resistance is assessed.
Measured: thirty-five weeks
Body Mass Index (BMI)
It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
Measured: thirty-five weeks
Body fat percentage
is total fat mass divided by total body mass, multiplied by 100. This is another obesity indicator like BMI.
Measured: thirty-five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start31 Jul 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal prospective, controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Polo Ferrero, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957133
- Sponsor's protocol ID
- USalamancaAO
- Acronym
- OAMT
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect on Functionality of Multicomponent Training With and Without Action Observation in Older Adults.
- ClinicalTrials.gov ID
- NCT05957133
- Acronym / sponsor ID
- OAMT / USalamancaAO
- Keywords
- exercise, elderly, multicomponent exercise, Action Observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 31 Jul 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 24 Jul 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.
Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. At the beginning and at the end of the programme, data were collected on participants' balance, fall risk and other parameters, using anthropometric tests (weight, % body fat and body mass index (BMI)), and physical performance tests (grip strength, the Short Physical Performance Battery, TUG and the stair step test). Study participants performed three 50-minute sessions per week for a total of 35 weeks. The components of balance, gait, cardiovascular resistance, stability, upper and lower limb strength, flexibility and breathing exercises were worked on. In the OC group, the physiotherapist performed the entire session together with the participants, while in the other group, the physiotherapist simply ordered the exercises.
Detailed description
Design: Randomised, controlled clinical trial with two parallel groups, in which adults over 65 years of age will be recruited. Study participants will be assigned to one of the two interventions. The study will have a duration of 35 weeks. There will be 2 evaluation visits, one initial, one final. During the intervention period there will be 3 weekly sessions of 50 minutes.
Scope: The study will be carried out in the Health Area of Salamanca, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multicomponent Exercise Group (GEM); 2) Multicomponent Exercise and Action Observation Group (GOA). The GEM and GOA sessions follow the same design, according to the recommendations of the American College of Sports Medicine (ACSM), the only difference being that in the GOA the physiotherapist will perform all the exercises with the participants.
Study population: Adults over 65 years of age from the city of Salamanca will be included, distributed in 2 groups in a 1:1 ratio. Randomisation will be performed using the Epidat 4.2 programme. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Functionality (Timed Up \& Go test (TUG), chair stand test (CS), hand grip test (HG) and Short Physical Performance Battery (SPPB)), gait speed (GS). stair step test; and body composition (% body fat, body weight, body mass index (BMI)).
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric Student's t-test will be used, and if they are non-parametric the Wilcoxon test will be used. An alpha risk of 0.05 is established as the limit of statistical significance. The statistical programme to be used will be SPSS, v.26.0.
The study will be carried out with the authorisation of the Ethics Committee for Research with Medicines (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. Participants will be informed of the objectives of the project and of the risks and benefits of the tests and interventions to be performed. The study has been designed and subsequently evaluated in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research on human beings, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Longitudinal prospective, controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise group without action observation (MTG) | Active comparator | Procedure: Multicomponent exercise without action observation.The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the different models is as follows: E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work. E. Strength: Increase sets, repetitions and decrease rest time. Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc. Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making. |
| Multicomponent exercise group associated to action observation (AOG) | Experimental | Procedure: Multicomponent exercise associated with action observationIt is the same intervention as the other group with the addition of the observation of actions thanks to the fact that the physiotherapist carries out the exercises with them at all times. The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the exercises will be the same as in the other group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- adults over 65 years of age.
Key exclusion criteria (10 listed)
- Tumors
- Pacemakers
- Fibrillations
- Cardiac pathology or uncontrolled hypertension
- History of severe trauma/recent cervical surgery
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 |
|---|---|---|
| Multicomponent exercise without action observation.Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises. | Procedure or surgery | Multicomponent exercise group without action observation (MTG) |
| Multicomponent exercise associated with action observationDifferent exercise modalities are integrated: aerobic, mobility, strength, balance and coordination exercises carried out at all times by the physiotherapist and observed by the participants. | Procedure or surgery | Multicomponent exercise group associated to action observation (AOG) |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: thirty-five weeks
Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
7 secondary outcomes
Gait speed
Time frame: thirty-five weeks
Timed Up and Go (TUG)
Time frame: thirty-five weeks
Grip strength test
Time frame: thirty-five weeks
Chair stand test
Time frame: thirty-five weeks
Step-Up Box Test
Time frame: thirty-five weeks
Body Mass Index (BMI)
Time frame: thirty-five weeks
Body fat percentage
Time frame: thirty-five weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise without action observation. and Multicomponent exercise associated with action observation in people with Aging and Exercise, run by University of Salamanca.
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 10 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Polo Ferrero, MsC (6899919744, pfluis@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: thirty-five weeks). 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 24 Jul 2023.