Active Retirement: Effects of the Application of a Training Program

Sponsor

University of Évora (Other)

Overall Status

Recruiting

CT.gov ID

NCT05398354

Collaborator

(none)

160

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Training Sensorimotor Disorder	Behavioral: Active retirement	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Retirement - intervention 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 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.
No Intervention: Active Retirement - control 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.

Arm

Intervention/Treatment

Experimental: Active Retirement - intervention

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

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.

No Intervention: Active Retirement - control

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.

Outcome Measures

Primary Outcome Measures

Body weight [1 year]
Weight evaluation will be done using a scale
Height [1 year]
Height evaluation will be done using a stadiometer
Lower limbs muscle strength [1 year]
Lower limbs muscle strength will be evaluated with chair stand-up test
Upper limbs muscle strength [1 year]
The muscle strength of the upper limbs will be evaluated by forearm flexion test
Lower limbs flexibility [1 year]
Lower limbs flexibility will be evaluated through the "sit and reach"
Upper limbs flexibility [1 year]
The flexibility of the upper limbs will be assessed through "reaching behind the back"
Postural control [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 [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 [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 Outcome Measures

Life Quality [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.
Physical activity level [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.
Effort intensity [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.
Level of satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Alexandra Cabo	Évora		Portugal	7000-812

Sponsors and Collaborators

University of Évora

Investigators

Principal Investigator: Carolina A Cabo, University of Évora

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Carolina Alexandra Cabo, Principal Investigator, University of Évora

ClinicalTrials.gov Identifier:

NCT05398354

Other Study ID Numbers:

21040

First Posted:

May 31, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carolina Alexandra Cabo, Principal Investigator, University of Évora

Study Results

No Results Posted as of Jun 2, 2022