Healthy Aging, Overweight and Obesity, Physical Fitness, Psychological Well-being
Conditions
Keywords
Multidomain exercise, Older women, Physical fitness, Motivation for physical activity, Anthropometric variables, Self-Determination Theory, Randomized controlled trial, Exercise intervention
Brief summary
The goal of this clinical trial is to learn whether a long-term exercise program can improve physical health and well-being in older women aged 60 years and older who live in the community. 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
This study is a randomized controlled clinical trial designed to examine the effects of a long-term supervised exercise program on physical and psychological outcomes in older women. 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.
Interventions
BEHAVIORALSupervised 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.
Sponsors
Universidade do Oeste de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study. Due to the nature of the exercise intervention, neither participants, care providers, investigators, nor outcome assessors were blinded to group allocation.
Intervention model description
Parallel-group randomized controlled trial with two arms (experimental and control), with participants allocated in a 2:1 ratio and followed for 12 months.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 60 years or older. * 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
* Presence of severe cardiovascular, respiratory, neurological, or musculoskeletal diseases that contraindicate physical exercise. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Girth | Baseline and 12 months | Change in waist girth after 12 months of intervention, measured in centimeters (cm). |
| Gait Speed (10-Meter Walk Test) | Baseline and 12 months | Change in gait speed after 12 months of intervention, assessed using the 10-meter walk test (10MWT), which measures the time needed to walk a distance of 10 meters at a fast and safe pace (seconds). |
| Lower Limb Functional Strength (Five-Times Sit-to-Stand Test) | Baseline and 12 months | Change in lower limb functional strength after 12 months of intervention, assessed using the five-times sit-to-stand test (FTSST), which measures the time needed to stand up and sit down five times from a chair (seconds). |
| Functional Mobility (Timed Up and Go Test) | Baseline and 12 months | Change in functional mobility after 12 months of intervention, assessed using the Timed Up and Go test (TUG), which measures the time needed to stand up from a chair, walk a short distance, turn around, return, and sit down again (seconds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomous Regulation for Physical Activity | Baseline and 12 months | Change in autonomous regulation after 12 months of intervention, assessed using the Treatment Self-Regulation Questionnaire for Physical Activity (TSRQ-PA), a questionnaire that measures reasons for being physically active (score range: 1 to 7). |
| Perceived Health Care Climate | Baseline and 12 months | Change in perceived autonomy support after 12 months of intervention, assessed using the Health Care Climate Questionnaire (HCCQ), which measures perceived support from health professionals (score range: 1 to 7). |
| Controlled Regulation for Physical Activity | Baseline and 12 months | Change in controlled regulation after 12 months of intervention, assessed using the Treatment Self-Regulation Questionnaire for Physical Activity (TSRQ-PA), which measures externally driven reasons for physical activity (score range: 1 to 7). |
| Amotivation | Baseline and 12 months | Change in amotivation after 12 months of intervention, assessed using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3), which measures lack of motivation for physical activity (score range: 1 to 5). |
| Basic Psychological Needs Satisfaction | Baseline and 12 months | Change in autonomy, competence, and relatedness after 12 months of intervention, assessed using the Basic Need Satisfaction in General Scale (BNSG), which measures satisfaction of basic psychological needs (score range: 1 to 7). |
Countries
Brazil
Outcome results
None listed