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临床试验/NCT07685392
NCT07685392已完成不适用

Effects of a Progressive Strength and Balance Exercise Program on Falls in Postmenopausal Women With Osteoporosis: A Randomized Controlled Pilot Trial

Instituto Nacional de Rehabilitacion1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Occurrence of at least one fall

研究概览

简要总结

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.

详细描述

Postmenopausal osteoporosis is associated with an increased risk of fragility fractures, functional decline, disability, and loss of independence. Falls are a major modifiable pathway leading to fragility fractures in older adults. Exercise-based fall-prevention strategies, particularly those including balance and resistance training, may improve muscle strength, postural control, gait performance, and confidence during mobility. However, evidence remains limited regarding structured progressive exercise programs specifically evaluated in postmenopausal women with osteoporosis in clinical rehabilitation settings.

This study was designed as a single-center, single-blind, randomized, parallel-assignment pilot trial conducted in postmenopausal women with osteoporosis. The objective was to evaluate the effects of a supervised progressive strength and balance exercise program on fall occurrence and fractures compared with a conventional home-based exercise program. A secondary objective was to explore whether baseline functional measures, including balance performance and handgrip strength, were associated with fall occurrence during follow-up.

Eligible participants were postmenopausal women aged 60 to 80 years with osteoporosis confirmed by dual-energy X-ray absorptiometry, defined as a T-score <= -2.5 at the lumbar spine, total hip, or femoral neck. Participants were recruited from the Osteoarticular Rehabilitation Service of the Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico. The protocol was initiated in 2019; however, study activities were suspended during the COVID-19 pandemic. The final analyzed sample consisted of 46 participants recruited consecutively by convenience sampling between 2023 and 2025.

After baseline assessment, participants were randomly allocated to either the supervised progressive strength and balance exercise program or the home-based conventional exercise program. Randomization was performed using a random-number table, and allocation was concealed using opaque, sealed, sequentially numbered envelopes that were opened after completion of baseline assessment. Outcome assessments were performed by an evaluator blinded to group allocation. Participants and treating therapists could not be blinded because of the nature of the exercise intervention.

Participants in both groups were instructed to perform home exercises three times per week, with each session lasting approximately 60 minutes, for 6 months. Adherence of at least 80% of prescribed sessions was considered adequate. Before starting the exercise program, anteroposterior and lateral thoracolumbar and sacral spine radiographs were obtained to identify asymptomatic vertebral fractures. Incident fractures during follow-up were corroborated by available clinical imaging, including radiography or computed tomography.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women aged 60 to 80 years.
  • Diagnosis of osteoporosis confirmed by dual-energy X-ray absorptiometry, defined as a T-score <= -2.5 at the lumbar spine, total hip, or femoral neck.
  • Ability to participate safely in an exercise program as judged by the investigators.
  • Ability to understand and follow study instructions.
  • Written informed consent provided before enrollment.
  • Clinical conditions that precluded safe participation in exercise.
  • Severe neurological disorders affecting independent mobility.
  • Severe musculoskeletal disorders affecting independent mobility.
  • Inability to follow instructions.
  • Any other condition judged by the investigators to interfere with the intervention or outcome assessment.

排除标准

  • Clinical conditions that precluded safe participation in exercise.
  • Severe neurological disorders affecting independent mobility.
  • Severe musculoskeletal disorders affecting independent mobility.
  • Inability to follow instructions.
  • Any other condition judged by the investigators to interfere with the intervention or outcome assessment.

结局指标

主要结局

Occurrence of at least one fall

时间窗: 6 months

Description: Proportion of participants with at least one fall during the 6-month follow-up period. A fall was defined as an involuntary, accidental, and non-intentional event in which the participant descended to the ground, floor, or a lower surface from standing height or lower, without a high-energy mechanism. Falls were coded as present or absent.

次要结局

未报告次要终点

研究者

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

Salvador Israel Macías-Hernández

Principal Investigator

Instituto Nacional de Rehabilitacion

研究点 (1)

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