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临床试验/NCT07596602
NCT07596602已完成不适用

Feasibility and Preliminary Outcomes of a Machine-Based Pilates Program on Quality of Life and Low Back Pain in Aged Adults: A Mixed-Methods Approach

Instituto Politécnico de Leiria1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in Quality of Life

研究概览

简要总结

Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.

详细描述

The study is designed as an exploratory, quasi-experimental, single-arm pilot study. Participants presenting with moderate disability caused by low back pain (Oswestry Disability Index = 21% to 40%) will undergo a structured exercise protocol utilizing the Classical Pilates method on machines in a one-on-one setting. The intervention spans 12 weeks, consisting of two individual 50-minute sessions per week.

The pedagogical structure is divided into two distinct Classical approach components: the "Skeleton" (core base exercises on the Reformer and Mat) and the "System" (adaptations and specific exercises on auxiliary equipment like the Wunda Chair, Cadillac, and Barrels). Exercise progression is individualized based on biomechanical control, absence of pain, and ability to maintain a neutral lumbopelvic position. Resistance is modified primarily via adjustable springs on the equipment. Exercise intensity is strictly monitored using the Talk Test to ensure a light-to-moderate exertion level suitable for the geriatric demographic.

Assessments are conducted at baseline and post-intervention (12 weeks) using the WHOQOL-Bref for quality of life and the Oswestry Disability Index Version 2.0 for low back pain disability. Additionally, a qualitative focus group will be conducted post-intervention with a subsample of participants to capture contextual insights regarding mobility, psychosocial benefits, and daily habit integration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 55 and 75 years.
  • Physically active in daily routines.
  • No previous experience with machine-based Pilates.
  • Presenting with moderate disability (Oswestry Disability Index = 21% to 40%) caused by low back pain.

排除标准

  • Absolute contraindications to physical exercise.
  • Severe spinal pathologies (e.g., hernias requiring surgery, severe osteoporosis, idiopathic scoliosis).
  • Previous or scheduled spinal surgeries.
  • Severe disability (Oswestry Disability Index > 41%).
  • Chronic obstructive pulmonary disease.
  • Recent stroke or myocardial infarction.
  • Uncontrolled hypertension.
  • Active oncological treatment.
  • Physical therapy treatment for low back pain within the six months prior to the study.

研究组 & 干预措施

Machine-Based Pilates Group

Experimental

A 12-week program consisting of two individual 50-minute sessions per week. The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment). The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks). Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.

干预措施: Machine-Based Classical Pilates Program (Behavioral)

结局指标

主要结局

Change in Quality of Life

时间窗: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the World Health Organization Quality of Life Brief (WHOQOL-Bref) questionnaire. It evaluates four domains: physical, psychological, social relationships, and environment. Responses for each item are recorded on a five-point scale ranging from 1 (minimum) to 5 (maximum), and the total domain scores are transformed to a 0 to 100 scale, where 0 is the minimum possible score and 100 is the maximum possible score. Higher scores indicate a better perceived quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Filipe Fernandes Rodrigues

Principal Investigator

Instituto Politécnico de Leiria

研究点 (1)

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