Effects of a Multi-domain Exercise Program With Motivational Strategies on Anthropometric Variables, Physical Fitness, and Psychological Well-Being of Female Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Waist Girth
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Supervised Multidomain Exercise Program (Behavioral)
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.
结局指标
主要结局
Waist Girth
时间窗: Baseline and 12 months
Change in waist girth after 12 months of intervention, measured in centimeters (cm).
Lower Limb Functional Strength (Five-Times Sit-to-Stand Test)
时间窗: 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).
Gait Speed (10-Meter Walk Test)
时间窗: 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).
Functional Mobility (Timed Up and Go Test)
时间窗: 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).
次要结局
- Autonomous Regulation for Physical Activity(Baseline and 12 months)
- Amotivation(Baseline and 12 months)
- Controlled Regulation for Physical Activity(Baseline and 12 months)
- Basic Psychological Needs Satisfaction(Baseline and 12 months)
- Perceived Health Care Climate(Baseline and 12 months)
研究者
Gracielle Fin
Associate Professor and Researcher in Physical Education and Health Sciences
Universidade do Oeste de Santa Catarina