Impact of the Pilates Method on Quality of Life and Functional Well-Being in Women with Osteoporosis: Protocol for a...

Osteoporosis is a major public health concern among postmenopausal women, characterized by decreased bone mineral density and microarchitectural deterioration, which lead to fragility fractures, pain, functional impairment, sleep disturbances, and a reduced quality of life. Exercise, particularly strength, weight-bearing, and balance training, represents a key non-pharmacological approach to prevention and management. Pilates, a low-impact, core-centered method increasingly incorporated into rehabilitation settings, appears especially suitable for women with osteoporosis. However, high-quality randomized controlled trials concurrently evaluating its effects on pain, balance, sleep, autonomy, and health-related quality of life remain scarce.

To examine the efficacy and feasibility of a Pilates-based exercise program in improving pain, balance, sleep quality, functional autonomy, and quality of life in postmenopausal women with osteoporosis.

A single-blind, parallel-group, randomized controlled trial will be conducted over 12 weeks at Physiocare Madrid (Spain). A total of 126 (63 per group) postmenopausal women aged 50-80 years, diagnosed with osteoporosis by densitometry or with a prior fragility fracture, will be randomly assigned (1:1; OxMaR software, version 2014) to one of two groups: (a) Experimental group: supervised Pilates mat sessions, 60 min, twice weekly for 12 weeks; or (b) Control group: ergonomics education for activities of daily living, two 60 min sessions held six weeks apart. Outcome assessors will remain blinded to group allocation. Evaluations will be conducted at baseline and post-intervention. Outcome measures will include balance and mobility (Timed Up and Go Test; Functional Reach Test), functional autonomy (Functional Independence Measure), pain intensity (Visual Analog Scale), sleep quality (Pittsburgh Sleep Quality Index), health-related quality of life (WHOQOL-BREF; QUALEFFO-41), and treatment satisfaction (CSQ-8). Feasibility parameters (recruitment, adherence, retention, and safety) will also be monitored. Data will be pseudonymized and analyzed descriptively to estimate variability and preliminary effects, informing the design of a definitive trial.

It is hypothesized that Pilates will produce clinically meaningful improvements in balance, pain, sleep quality, and health-related quality of life compared with ergonomics education, with acceptable feasibility and safety outcomes.

This randomized controlled trial will provide initial evidence regarding the efficacy and feasibility of Pilates as a complementary rehabilitation strategy for women with osteoporosis and provide key parameters to optimizing a future adequately powered trial.

This study will be conducted in accordance with the principles of the Declaration of Helsinki and has been approved by the Human Ethics Committee of Universidad Rey Juan Carlos. Potential risks will be minimized, and any adverse events will be systematically recorded and addressed.