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Completed

NCT Number: NCT05398354

Active Retirement: Effects of the Application of a Training Program

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.

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Key information

Conditions

Training Sensorimotor Disorder

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Alexandra Cabo

Evora, 7000-812, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Active retirement

Behavioral

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.

Primary outcomes

  1. Body weight

    Time frame: 1 year

    Weight evaluation will be done using a scale

  2. Height

    Time frame: 1 year

    Height evaluation will be done using a stadiometer

  3. Lower limbs muscle strength

    Time frame: 1 year

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

  4. Upper limbs muscle strength

    Time frame: 1 year

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

  5. Lower limbs flexibility

    Time frame: 1 year

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

  6. Upper limbs flexibility

    Time frame: 1 year

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

  7. 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).

  8. 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)

  9. 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.

Secondary outcomes

  1. Life Quality

    Time frame: 1 year

    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.

  2. Physical activity level

    Time frame: 1 year

    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.

  3. Effort intensity

    Time frame: 1 year

    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.

  4. Level of satisfaction

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Évora

Other

Registry information

Official study title

Active Retirement: Effects of the Application of a Training Program on the Stimulation of the Sensory Motor System

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 31, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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