Multi-Domain Exercise Program In Older Women (MD-EX Women)

Universidade do Oeste de Santa Catarina

Status: Completed

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

Treatments: Behavioral: Supervised Multidomain Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07311265

71244423.0.0000.5367

Details and patient eligibility

About

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

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Supervised Multidomain Exercise Program

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised Multidomain Exercise Program

Usual Daily Activities (No Structured Exercise)

No Intervention group

Description:

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.