Progressive Strength and Balance Exercise for Fall Prevention in Postmenopausal Women With Osteoporosis

NCT07685392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-07-06

No results posted yet for this study

Summary

Postmenopausal osteoporosis increases the risk of fragility fractures, and falls are a major modifiable pathway leading to fracture. This single-blind randomized controlled pilot trial evaluated whether a supervised progressive strength and balance exercise program reduced fall occurrence compared with a conventional home-based exercise program in postmenopausal women with osteoporosis. Women aged 60 to 80 years with osteoporosis confirmed by dual-energy X-ray absorptiometry were randomly allocated to either a supervised progressive exercise program or a home-based exercise control group and were followed for 6 months. The primary outcome was the proportion of participants with at least one fall during follow-up. Secondary outcomes included incident fragility fractures, functional performance, balance, balance confidence, handgrip strength, gait speed, posturography parameters, adherence, and exercise-related adverse events. Exploratory analyses assessed whether baseline functional measures were associated with fall occurrence during follow-up. This record was submitted retrospectively after completion of participant enrollment and 6-month follow-up.

Conditions

  • Postmenopausal Osteoporosis
  • Accidental Falls, Aged, Exercise Movement Techniques
  • Fragility Fractures

Interventions

BEHAVIORAL

Supervised Progressive Strength and Balance Exercise Program

Participants received a supervised multicomponent exercise program consisting of progressive resistance training, core stabilization exercises, and balance training. The intervention began with 10 supervised institutional sessions delivered Monday through Friday over two consecutive weeks. During this phase, participants were instructed in proper exercise performance and progression. After supervised training, participants performed the program at home three times per week for 6 months, with each session lasting approximately 60 minutes. Progressive resistance training was prescribed using an estimated 10-repetition maximum, with progression every four weeks by increasing repetitions or external load. Core stabilization exercises progressed monthly through predefined positions, while balance training followed a structured 14-level progression according to participant performance. Follow-up visits at 1, 3, and 6 months reinforced adherence, monitored safety, and advanced exercise diffic

BEHAVIORAL

Home-Based Conventional Exercise Program

Participants received one individual 60-minute instructional session and a printed home-exercise program representing the conventional physical therapy routinely prescribed by the rehabilitation service. The program included postural correction exercises, static single-leg balance, balance on an irregular surface, dynamic balance exercises, and initial stabilization exercises performed in supine and anterior bridge positions. Participants were instructed to perform the exercises at home three times per week for 6 months, with each session lasting approximately 60 minutes. Unlike the experimental intervention, the control program did not include a structured progression of exercise intensity or difficulty. Follow-up visits at 1, 3, and 6 months reinforced adherence and monitored falls, fractures, and adverse events.

Sponsors & Collaborators

  • Instituto Nacional de Rehabilitacion

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-07-01
Completion
2025-12-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685392 on ClinicalTrials.gov