Multi-Domain Exercise Program In Older Women

NCT07311265 | Completed

• 1 other identifier: 71244423.0.0000.5367
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Aging; Overweight and Obesity; Physical Fitness; Psychological Well-being

Keywords

Multidomain exercise; Older women; Physical fitness; Motivation for physical activity; Anthropometric variables; Self-Determination Theory; Randomized controlled trial; Exercise intervention

Outcome Measures

Primary Outcomes (4)

• Waist Girth

  Change in waist girth after 12 months of intervention, measured in centimeters (cm).

  Baseline and 12 months

• Gait Speed (10-Meter Walk Test)

  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).

  Baseline and 12 months

• Lower Limb Functional Strength (Five-Times Sit-to-Stand Test)

  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).

  Baseline and 12 months

• Functional Mobility (Timed Up and Go Test)

  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).

  Baseline and 12 months

Secondary Outcomes (5)

• Autonomous Regulation for Physical Activity

  Baseline and 12 months

• Controlled Regulation for Physical Activity

  Baseline and 12 months

• Amotivation

  Baseline and 12 months

• Basic Psychological Needs Satisfaction

  Baseline and 12 months

• Perceived Health Care Climate

  Baseline and 12 months

Study Arms (2)

Supervised Multidomain Exercise Program

EXPERIMENTAL

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.

Behavioral: Supervised Multidomain Exercise Program

Usual Daily Activities (No Structured Exercise)

NO INTERVENTION

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.

Interventions

Supervised Multidomain Exercise Program BEHAVIORAL

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.

Also known as: Multidomain Training Program

Supervised Multidomain Exercise Program

Eligibility Criteria

• Age: 60 Years - 100 Years
• Gender Eligibility Details: Only individuals who self-identify as women and meet the biological sex eligibility criteria (female at birth) are eligible to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Oeste de Santa Catarina: lead

Study Sites (1)

Gracielle Fin

Joaçaba, Santa Catarina, 89600000, Brazil

Location

MeSH Terms

Conditions

Overweight; Obesity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Gracielle Fin, PhD

  Universidade do Oeste de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Researcher in Physical Education and Health Sciences

Model Details: Parallel-group randomized controlled trial with two arms (experimental and control), with participants allocated in a 2:1 ratio and followed for 12 months.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 30, 2025
• Study Start: March 10, 2023
• Primary Completion: November 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)