TrainingNCT05398354
Active Retirement: Effects of the Application of a Training Program
A study testing Active retirement in people with Training and Sensorimotor Disorder, run by University of Évora at 1 site in Portugal.
Trial summary
The study will include 160 participants. They will be randomized into 2 groups, experimental and control. The intervention will take place over 24 weeks. Parameters of body composition, quality of life, physical activity, strength, flexibility, postural control, gait, agility and execution speed will be determined. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Training, Sensorimotor Disorder
- What is being tested?
- Active retirement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2021to 30 Jul 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 55 years and 80 years;
- Agree to participate in the study;
- Healthy people;
- People without prostheses (with the exception of dental prostheses);
- People who have not been operated on for less than 6 months.
Who cannot join
- People with musculoskeletal diagnosis;
- People with problems in locomotion;
- Psychiatric diseases and neurological disorders;
- People with a clinical cardiovascular diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Retirement: Effects of the Application of a Training Program on the Stimulation of the Sensory Motor System
The study will include 160 participants. They will be randomized into 2 groups, experimental and control. The intervention will take place over 24 weeks. Parameters of body composition, quality of life, physical activity, strength, flexibility, postural control, gait, agility and execution speed will be determined.
Read the detailed description
The intervention study will have a quasi-experimental, longitudinal and controlled design. The sample will participate in a supervised training program lasting 24 weeks, followed by a 1-year follow-up period. The sample will be divided into two groups, intervention group and control group.
The variables under study are physical activity in the last week; quality of life; lower and upper limb strength; flexibility of the lower and upper limbs; postural control; march; agility and execution speed. These variables will be evaluated in 4 moments: before the beginning of the training program; after 24 weeks of the program; after 6 months from the end of the program; and after 1 year.
A convenience sample will be recruited in the community of Almada, in partnership with the Municipality of Almada (CMA). The sample will be recruited according to the following inclusion criteria: residents in the municipality of Almada, individuals between 55 and 80 years of age, healthy people, who do not have prostheses (with the exception of dental prostheses), who have not undergone operations for over 6 months, and who can walk independently for up to 10 minutes. Participants will not be eligible if they are younger than 55 years of age or older than 80 years of age, have a musculoskeletal or neurological diagnosis and report a clinical cardiovascular diagnosis. Gender is not an exclusion criterion.
The training program will be carried out over a period of 24 weeks, with exercise sessions twice a week, lasting approximately 45 minutes each. The sessions were divided into three phases: initial phase; fundamental phase; and return to calm. Throughout the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy, intermediate and advanced.
- Conditions
- Training, Sensorimotor Disorder
- Being tested
- Active retirement
- Keywords
- aging, quality of life, sensory motor, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active retirementBehavioural
During the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy (without external load, during the first 8 weeks), intermediate (application of external load: elastic bands, shin guards and free weights, from the 9th to the 16th week) and advanced (increased external load compared to the previous level, from the 17th to the 24th week).
During the sessions we will still assess the intensity through the subjective perception of effort (RPE) scale. In addition, adherence and control of the level of control through the Physical Activity Enjoyment (PACES) survey applied to participants.
| Study group | Role | What they receive |
|---|---|---|
| Active Retirement - intervention | Experimental | The duration of the program is 24-weeks, 2-times a week, for up to 50 minutes per session. The sessions will be divided into three phases: the initial phase (10 minutes) will consist of a 5-minute walk followed by a joint warm-up; fundamental phase (25 minutes) will work in an exercise circuit, this circuit will consist of 4 cycles, with 8 exercises each, with a duration of 50 seconds and a rest of 15 seconds, for the exchange of exercise; and return to calm (10 minutes), where we will perform muscle stretching. Receives: Behavioral: Active retirement |
| Active Retirement - control | No intervention | The control group will only carry out the assessments and will be offered the same intervention as the intervention group at the end of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight evaluation will be done using a scale
Measured: 1 year
Height
Height evaluation will be done using a stadiometer
Measured: 1 year
Lower limbs muscle strength
Lower limbs muscle strength will be evaluated with chair stand-up test
Measured: 1 year
Upper limbs muscle strength
The muscle strength of the upper limbs will be evaluated by forearm flexion test
Measured: 1 year
Lower limbs flexibility
Lower limbs flexibility will be evaluated through the "sit and reach"
Measured: 1 year
Upper limbs flexibility
The flexibility of the upper limbs will be assessed through "reaching behind the back"
Measured: 1 year
Postural control
Postural control will be assessed using a force platform (Bertec4060-Columbus; USA). The evaluation will consist of measuring the oscillations in a static bipedal position, with eyes open (2 minutes) and with eyes closed (2 minutes).
Measured: 1 year
Gait
Gait will be evaluated using the mobile application "phyphox" on the inner edge of the tibia, on the surface of the skin, to quantify the number of steps and time), participants will be asked to walk a pre-established route, without slopes or obstacles, for 10 minutes at its natural cadence and then the same route at a rhythm determined by complex stimuli (auditory metronome - loudspeakers, which allow you to hear the beats, where each beat corresponds to a step)
Measured: 1 year
Agility and execution speed
Agility and speed of execution will be evaluated through the application of the Timed Up and Go (TUG) test, which consists of getting up from a chair, walking to a straight line 3 meters away, turning, walking back and sitting down again.
Measured: 1 year
Secondary outcomes (4)
Life Quality
Quality of life will be assessed using the general health and well-being questionnaire. The questionnaire consists of 11 questions ranging from 1 to 5, where 1 is absolutely true and 5 is absolutely false.
Measured: 1 year
Physical activity level
The practice of physical activity will be evaluated through the International Physical Activity Questionnaire. It does not have minimum and maximum values, the participants only indicate if they take place and in what period of time.
Measured: 1 year
Effort intensity
Intensity of effort will be evaluated through the subjective perception of exertion scale. The scale goes from 1 to 10 values, and the closer to 10 the activity requires maximum effort, it seems almost impossible to continue.
Measured: 1 year
Level of satisfaction
The level of satisfaction will be evaluated through the Physical Activity Enjoyment Scale. Scale from 1 to 7 values, the closer to 7 the more positive the physical activity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Sep 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TrainingStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Alexandra Cabo, University of Évora
- Investigators
- Carolina A Cabo, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398354
- Sponsor's protocol ID
- 21040
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bacha, J. M. R., Cordeiro, L. R., Alvisi, T. C., & Bonfim, T. R. (2016). Impacto do treinamento sensório-motor com plataforma vibratória no equilíbrio e na mobilidade funcional de um indivíduo idoso com sequela de acidente vascular encefálico: Relato de caso. Fisioterapia e Pesquisa, 23(1), 111-116. https://doi.org/10.1590/1809-2950/14362423012016
Costa, J. N., Avelar, B. P., Gonçalves, C. D., & Pereira, M. M. (2012). Efeitos do circuito de equilíbrio sobre o equilíbrio funcional e a possibilidade de quedas em idosas. Motricidade, 8, 485-492.
Gerhardy T, Gordt K, Jansen CP, Schwenk M. Towards Using the Instrumented Timed Up-and-Go Test for Screening of Sensory System Performance for Balance Control in Older Adults. Sensors (Basel). 2019 Feb 1;19(3):622. doi: 10.3390/s19030622.
PubMed 30717202Gléria, P. D. M. P., & Sandoval, R. A. (2011). Treinamento funcional como recurso fisioterapêutico para o aprimoramento da força muscular e equilíbrio de idosos. EFDeportes.com, Revista Digital, 161.
Martins, M. M., Monteiro, C., Martinho, J., Guerra-Martín, M. D., Alves, I., & Vieira, M. (2016). Atividade física nos mais de 65 anos e a Promoção da Saúde. Actas de Gerontologia, 2(1).
McGarrigle L, Boulton E, Todd C. Map the apps: a rapid review of digital approaches to support the engagement of older adults in strength and balance exercises. BMC Geriatr. 2020 Nov 18;20(1):483. doi: 10.1186/s12877-020-01880-6.
PubMed 33208117Pierratos, T., & Polatoglou, H. M. (2020). Utilizing the phyphox app for measuring kinematics variables with a smartphone. Physics Education, 55(2), 025019. https://doi.org/10.1088/1361-6552/ab6951
Ready, E. A. (2019). Optimizing Gait Outcomes in Parkinson's Disease with Auditory Cues: The Effects of Synchronization, Groove, and Beat Perception Ability [The University of Western Ontario]. https://ir.lib.uwo.ca/etd
Rezende, A. A. B., Silva, I. L. e, Beresford, H., & Batista, L. A. (2012). Avaliação dos efeitos de um programa sensório-motor no padrão da marcha de idosas. Fisioterapia em Movimento, 25(2), 317-324. https://doi.org/10.1590/S0103-51502012000200009
Rikli, R. E., & Jones, C. J. (1999). Development and Validation of a Functional Fitness Test for Community-Residing Older Adults. Journal of Aging and Physical Activity, 7(2), 129-161. https://doi.org/10.1123/japa.7.2.129
Rosa, B. P. de. S. (2012). Envelhecimento, Força Muscular e Atividade Física: Uma breve revisão bibliográfica. Revista Científica FacMais, 2(1), 140-152.
Salehi, R., Ebrahimi-Takamjani, I., Esteki, A., Maroufi, N., & Parnianpour, M. (2010). Test-retest reliability and minimal detectable change for center of pressure measures of postural stability in elderly subjects. Medical Journal of the Islamic Republic of Iran, 23(4), 224-232.
Sampaio, L. V. P., Castilho, L. B., & Carvalho, G. de A. (2017). Development of an application for mobile devices to evaluate the balance and risk of falls of the elderly. Revista Brasileira de Geriatria e Gerontologia, 20(6), 805-813. https://doi.org/10.1590/1981-22562017020.170017
Serviço Nacional de Saúde. (2017). Tropeções, quedas e trambolhões. https://www.sns.gov.pt/noticias/2017/12/19/tropecoes-quedas-e-trambolhoes/
Serviço Nacional de Saúde. (2018). Portal da Direção Nacional de Saúde. https://www.dgs.pt/programa-nacional-para-a-promocao-da-atividade-fisica/perguntas-e-respostas.aspx
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Retirement: Effects of the Application of a Training Program on the Stimulation of the Sensory Motor System
- ClinicalTrials.gov ID
- NCT05398354
- Acronym / sponsor ID
- 21040
- Conditions
- Training, Sensorimotor Disorder
- Keywords
- aging, quality of life, sensory motor, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 31 May 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.
The study will include 160 participants. They will be randomized into 2 groups, experimental and control. The intervention will take place over 24 weeks. Parameters of body composition, quality of life, physical activity, strength, flexibility, postural control, gait, agility and execution speed will be determined.
Detailed description
The intervention study will have a quasi-experimental, longitudinal and controlled design. The sample will participate in a supervised training program lasting 24 weeks, followed by a 1-year follow-up period. The sample will be divided into two groups, intervention group and control group.
The variables under study are physical activity in the last week; quality of life; lower and upper limb strength; flexibility of the lower and upper limbs; postural control; march; agility and execution speed. These variables will be evaluated in 4 moments: before the beginning of the training program; after 24 weeks of the program; after 6 months from the end of the program; and after 1 year.
A convenience sample will be recruited in the community of Almada, in partnership with the Municipality of Almada (CMA). The sample will be recruited according to the following inclusion criteria: residents in the municipality of Almada, individuals between 55 and 80 years of age, healthy people, who do not have prostheses (with the exception of dental prostheses), who have not undergone operations for over 6 months, and who can walk independently for up to 10 minutes. Participants will not be eligible if they are younger than 55 years of age or older than 80 years of age, have a musculoskeletal or neurological diagnosis and report a clinical cardiovascular diagnosis. Gender is not an exclusion criterion.
The training program will be carried out over a period of 24 weeks, with exercise sessions twice a week, lasting approximately 45 minutes each. The sessions were divided into three phases: initial phase; fundamental phase; and return to calm. Throughout the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy, intermediate and advanced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Retirement - intervention | Experimental | Behavioral: Active retirementThe duration of the program is 24-weeks, 2-times a week, for up to 50 minutes per session. The sessions will be divided into three phases: the initial phase (10 minutes) will consist of a 5-minute walk followed by a joint warm-up; fundamental phase (25 minutes) will work in an exercise circuit, this circuit will consist of 4 cycles, with 8 exercises each, with a duration of 50 seconds and a rest of 15 seconds, for the exchange of exercise; and return to calm (10 minutes), where we will perform muscle stretching. |
| Active Retirement - control | No intervention | –The control group will only carry out the assessments and will be offered the same intervention as the intervention group at the end of the intervention. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 55 years and 80 years;
- Agree to participate in the study;
- Healthy people;
- People without prostheses (with the exception of dental prostheses);
- People who have not been operated on for less than 6 months.
Key exclusion criteria (4 listed)
- People with musculoskeletal diagnosis;
- People with problems in locomotion;
- Psychiatric diseases and neurological disorders;
- People with a clinical cardiovascular diagnosis.
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 |
|---|---|---|
| Active retirementDuring the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy (without external load, during the first 8 weeks), intermediate (application of external load: elastic bands, shin guards and free weights, from the 9th to the 16th week) and advanced (increased external load compared to the previous level, from the 17th to the 24th week). During the sessions we will still assess the intensity through the subjective perception of effort (RPE) scale. In addition, adherence and control of the level of control through the Physical Activity Enjoyment (PACES) survey applied to participants. | Behavioural | Active Retirement - intervention |
Primary outcome
Body weight
Time frame: 1 year
Weight evaluation will be done using a scale
Height
Time frame: 1 year
Height evaluation will be done using a stadiometer
Lower limbs muscle strength
Time frame: 1 year
Lower limbs muscle strength will be evaluated with chair stand-up test
Upper limbs muscle strength
Time frame: 1 year
The muscle strength of the upper limbs will be evaluated by forearm flexion test
Lower limbs flexibility
Time frame: 1 year
Lower limbs flexibility will be evaluated through the "sit and reach"
Upper limbs flexibility
Time frame: 1 year
The flexibility of the upper limbs will be assessed through "reaching behind the back"
Postural control
Time frame: 1 year
Postural control will be assessed using a force platform (Bertec4060-Columbus; USA). The evaluation will consist of measuring the oscillations in a static bipedal position, with eyes open (2 minutes) and with eyes closed (2 minutes).
Gait
Time frame: 1 year
Gait will be evaluated using the mobile application "phyphox" on the inner edge of the tibia, on the surface of the skin, to quantify the number of steps and time), participants will be asked to walk a pre-established route, without slopes or obstacles, for 10 minutes at its natural cadence and then the same route at a rhythm determined by complex stimuli (auditory metronome - loudspeakers, which allow you to hear the beats, where each beat corresponds to a step)
Agility and execution speed
Time frame: 1 year
Agility and speed of execution will be evaluated through the application of the Timed Up and Go (TUG) test, which consists of getting up from a chair, walking to a straight line 3 meters away, turning, walking back and sitting down again.
4 secondary outcomes
Life Quality
Time frame: 1 year
Physical activity level
Time frame: 1 year
Effort intensity
Time frame: 1 year
Level of satisfaction
Time frame: 1 year
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 1 Dec 2023.
- BackgroundBacha, J. M. R., Cordeiro, L. R., Alvisi, T. C., & Bonfim, T. R. (2016). Impacto do treinamento sensório-motor com plataforma vibratória no equilíbrio e na mobilidade funcional de um indivíduo idoso com sequela de acidente vascular encefálico: Relato de caso. Fisioterapia e Pesquisa, 23(1), 111-116. https://doi.org/10.1590/1809-2950/14362423012016
- BackgroundCosta, J. N., Avelar, B. P., Gonçalves, C. D., & Pereira, M. M. (2012). Efeitos do circuito de equilíbrio sobre o equilíbrio funcional e a possibilidade de quedas em idosas. Motricidade, 8, 485-492.
- Background: PubMed 30717202Gerhardy T, Gordt K, Jansen CP, Schwenk M. Towards Using the Instrumented Timed Up-and-Go Test for Screening of Sensory System Performance for Balance Control in Older Adults. Sensors (Basel). 2019 Feb 1;19(3):622. doi: 10.3390/s19030622.
- BackgroundGléria, P. D. M. P., & Sandoval, R. A. (2011). Treinamento funcional como recurso fisioterapêutico para o aprimoramento da força muscular e equilíbrio de idosos. EFDeportes.com, Revista Digital, 161.
- BackgroundMartins, M. M., Monteiro, C., Martinho, J., Guerra-Martín, M. D., Alves, I., & Vieira, M. (2016). Atividade física nos mais de 65 anos e a Promoção da Saúde. Actas de Gerontologia, 2(1).
- Background: PubMed 33208117McGarrigle L, Boulton E, Todd C. Map the apps: a rapid review of digital approaches to support the engagement of older adults in strength and balance exercises. BMC Geriatr. 2020 Nov 18;20(1):483. doi: 10.1186/s12877-020-01880-6.
- BackgroundPierratos, T., & Polatoglou, H. M. (2020). Utilizing the phyphox app for measuring kinematics variables with a smartphone. Physics Education, 55(2), 025019. https://doi.org/10.1088/1361-6552/ab6951
- BackgroundReady, E. A. (2019). Optimizing Gait Outcomes in Parkinson's Disease with Auditory Cues: The Effects of Synchronization, Groove, and Beat Perception Ability [The University of Western Ontario]. https://ir.lib.uwo.ca/etd
- BackgroundRezende, A. A. B., Silva, I. L. e, Beresford, H., & Batista, L. A. (2012). Avaliação dos efeitos de um programa sensório-motor no padrão da marcha de idosas. Fisioterapia em Movimento, 25(2), 317-324. https://doi.org/10.1590/S0103-51502012000200009
- BackgroundRikli, R. E., & Jones, C. J. (1999). Development and Validation of a Functional Fitness Test for Community-Residing Older Adults. Journal of Aging and Physical Activity, 7(2), 129-161. https://doi.org/10.1123/japa.7.2.129
- BackgroundRosa, B. P. de. S. (2012). Envelhecimento, Força Muscular e Atividade Física: Uma breve revisão bibliográfica. Revista Científica FacMais, 2(1), 140-152.
- BackgroundSalehi, R., Ebrahimi-Takamjani, I., Esteki, A., Maroufi, N., & Parnianpour, M. (2010). Test-retest reliability and minimal detectable change for center of pressure measures of postural stability in elderly subjects. Medical Journal of the Islamic Republic of Iran, 23(4), 224-232.
- Individual participant dataSharing planned: Undecided
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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.
Carolina A Cabo principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active retirement in people with Training and Sensorimotor Disorder, run by University of Évora at 1 site in Portugal.
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 5 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 1 Dec 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 Portugal. 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?
Body weight (time frame: 1 year). The study lists 9 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 NCT05398354, which also lists 17 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 1 Dec 2023.