NCT05398354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

May 25, 2022

Last Update Submit

November 30, 2023

Conditions

Keywords

agingquality of lifesensory motortraining

Outcome Measures

Primary Outcomes (9)

  • Body weight

    Weight evaluation will be done using a scale

    1 year

  • Height

    Height evaluation will be done using a stadiometer

    1 year

  • Lower limbs muscle strength

    Lower limbs muscle strength will be evaluated with chair stand-up test

    1 year

  • Upper limbs muscle strength

    The muscle strength of the upper limbs will be evaluated by forearm flexion test

    1 year

  • Lower limbs flexibility

    Lower limbs flexibility will be evaluated through the "sit and reach"

    1 year

  • Upper limbs flexibility

    The flexibility of the upper limbs will be assessed through "reaching behind the back"

    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).

    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)

    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.

    1 year

Secondary Outcomes (4)

  • Life Quality

    1 year

  • Physical activity level

    1 year

  • Effort intensity

    1 year

  • Level of satisfaction

    1 year

Study Arms (2)

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.

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.

Interventions

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.

Active Retirement - intervention

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • People with musculoskeletal diagnosis;
  • People with problems in locomotion;
  • Psychiatric diseases and neurological disorders;
  • People with a clinical cardiovascular diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Alexandra Cabo

Evora, 7000-812, Portugal

Location

Related Publications (16)

  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30717202BACKGROUND
  • Gléria, 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 33208117BACKGROUND
  • Pierratos, 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Rosa, B. P. de. S. (2012). Envelhecimento, Força Muscular e Atividade Física: Uma breve revisão bibliográfica. Revista Científica FacMais, 2(1), 140-152.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • Serviço Nacional de Saúde. (2017). Tropeções, quedas e trambolhões. https://www.sns.gov.pt/noticias/2017/12/19/tropecoes-quedas-e-trambolhoes/

    BACKGROUND
  • 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

    BACKGROUND
  • Suzuki, K., Niitsu, M., Kamo, T., Otake, S., & Nishida, Y. (2019). Effect of Exercise with Rhythmic Auditory Stimulation on Muscle Coordination and Gait Stability in Patients with Diabetic Peripheral Neuropathy: A Randomized Controlled Trial. Open Journal of Therapy and Rehabilitation, 07(03), 79-91. https://doi.org/10.4236/ojtr.2019.73005

    BACKGROUND

Study Officials

  • Carolina A Cabo

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomization is performed using a random selection method from the waiting list and the data will be coded and transferred to the database, depending on the intervention group and control group. Data analysis will be done statistically. Each participant will be randomly assigned to each group after signing the informed consent and conducting the initial assessments. All laboratory samples and data collected will be identified with identification ID, safeguarding the confidentiality of the collected data. At the end of this study, all participants of the control group will be offered the same intervention as the exercise group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

September 1, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations