Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2023-03-10
2024-12-10
Brief Summary
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The main questions this study aims to answer are:
* Does taking part in a supervised exercise program lower waist size?
* Does the exercise program improve walking speed, leg strength, and the ability to move safely?
* Does the program improve motivation for physical activity and feelings of support and well-being?
Researchers will compare a Supervised Multi-Domain Exercise Program (intervention group) with Usual Daily Activities (No Structured Exercise) (control group) to see whether the supervised exercise program leads to better physical and psychological outcomes.
Participants will:
* Be randomly assigned to either the exercise program or a control group
* Take part in supervised exercise sessions twice a week for 12 months if assigned to the exercise group
* Complete physical tests, body measurements, and questionnaires about motivation and well-being at the start of the study and after 12 months
Detailed Description
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A total of 108 women aged 60 years and older who live independently in the community took part in the study. Participants were randomly assigned to one of two groups using a two-to-one ratio. One group was assigned to the Supervised Multi-Domain Exercise Program (intervention group), and the other group was assigned to Usual Daily Activities (No Structured Exercise) (control group).
Participants in the intervention group took part in supervised exercise sessions twice per week for 12 months. Each session lasted about 45 minutes and included a mix of activities focused on strength, walking and movement, balance, flexibility, and simple thinking tasks. Exercise intensity was adjusted to each participant and monitored throughout the program. Motivational strategies were included to support engagement and long-term participation in physical activity.
Participants in the control group continued their usual daily routines and did not take part in any structured or supervised exercise program during the study period.
All participants completed assessments at the start of the study and again after 12 months. These assessments included physical tests, body measurements, and questionnaires related to motivation and well-being. Trained researchers conducted all assessments using standardized procedures.
The study followed established guidelines for clinical trials and was approved by a local Research Ethics Committee. All participants provided written informed consent before taking part in the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Supervised Multidomain Exercise Program
Participants allocated to the experimental group participated in a supervised 12-month multi-domain exercise program including strength training, aerobic exercises, balance activities, flexibility, and cognitive tasks, combined with motivational and behavioral strategies.
Supervised Multidomain Exercise Program
Participants engaged in a supervised multi-domain exercise program conducted twice per week for 12 months, with each session lasting approximately 45 minutes. The program included neuromotor activities, muscle-strengthening exercises, aerobic training, balance exercises, flexibility activities, and simple cognitive tasks.
Exercise intensity was monitored using the Borg Category-Ratio 10 Rating of Perceived Exertion (CR-10), a simple scale that allows participants to rate how hard the exercise feels, along with an affective valence scale to monitor feelings of comfort or discomfort during exercise. Motivational strategies based on Self-Determination Theory (SDT) were incorporated throughout the intervention to support engagement and long-term participation.
Usual Daily Activities (No Structured Exercise)
Participants allocated to the control group maintained their usual daily routines and did not participate in any structured or supervised exercise program during the study period.
No interventions assigned to this group
Interventions
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Supervised Multidomain Exercise Program
Participants engaged in a supervised multi-domain exercise program conducted twice per week for 12 months, with each session lasting approximately 45 minutes. The program included neuromotor activities, muscle-strengthening exercises, aerobic training, balance exercises, flexibility activities, and simple cognitive tasks.
Exercise intensity was monitored using the Borg Category-Ratio 10 Rating of Perceived Exertion (CR-10), a simple scale that allows participants to rate how hard the exercise feels, along with an affective valence scale to monitor feelings of comfort or discomfort during exercise. Motivational strategies based on Self-Determination Theory (SDT) were incorporated throughout the intervention to support engagement and long-term participation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Living independently in the community.
* Ability to walk independently, with or without assistive devices.
* Medical clearance to participate in physical exercise.
* Willingness to participate in the exercise program for 12 months.
* Signed informed consent form.
Exclusion Criteria
* Cognitive impairment that prevents understanding of the study procedures.
* Participation in structured exercise programs more than twice per week in the last three months.
* Recent fractures or surgeries that limit physical activity.
* Any condition that, in the opinion of the research team, could compromise participant safety or adherence to the protocol.
60 Years
100 Years
FEMALE
Yes
Sponsors
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Universidade do Oeste de Santa Catarina
OTHER
Responsible Party
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Gracielle Fin
Associate Professor and Researcher in Physical Education and Health Sciences
Principal Investigators
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Gracielle Fin, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade do Oeste de Santa Catarina
Locations
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Gracielle Fin
Joaçaba, Santa Catarina, Brazil
Countries
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Other Identifiers
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71244423.0.0000.5367
Identifier Type: -
Identifier Source: org_study_id