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

NCT07685392 | Completed DMC

• 1 other identifier: 126_4-R
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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; Fragility Fractures; Accidental Falls, Aged, Exercise Movement Techniques

Keywords

Postmenopausal osteoporosis; Osteoporosis; Accidental falls; Fall prevention; Fragility fractures; Exercise therapy; Balance training; Progressive resistance training; Physical therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Occurrence of at least one fall

  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.

  6 months

Study Arms (2)

Supervised Progressive Strength and Balance Exercise Program

EXPERIMENTAL

Intervention Type: Behavioral Intervention Name: Supervised progressive strength and balance exercise program Description: A multicomponent exercise program including progressive resistance training, core stabilization, and balance exercises. Resistance exercises were based on an estimated 10-repetition maximum and progressed every 4 weeks. Core stabilization exercises were progressed monthly. Balance exercises followed a 14-level progression and were advanced at follow-up visits when appropriate.

Behavioral: Supervised Progressive Strength and Balance Exercise Program

Home-Based Conventional Exercise Program

ACTIVE COMPARATOR

Intervention Type: Behavioral Intervention Name: Home-based conventional exercise program Description: A home-based exercise program including postural correction exercises, static single-leg balance, balance on an irregular surface, dynamic balance exercises, and initial stabilization exercises. Unlike the experimental program, the control program did not include planned progression of exercise difficulty.

Behavioral: Home-Based Conventional Exercise Program

Interventions

Supervised Progressive Strength and Balance Exercise Program BEHAVIORAL

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

Supervised Progressive Strength and Balance Exercise Program

Home-Based Conventional Exercise Program BEHAVIORAL

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.

Home-Based Conventional Exercise Program

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

Location

Related Publications (5)

• Lima CA, Ricci NA, Nogueira EC, Perracini MR. The Berg Balance Scale as a clinical screening tool to predict fall risk in older adults: a systematic review. Physiotherapy. 2018 Dec;104(4):383-394. doi: 10.1016/j.physio.2018.02.002. Epub 2018 Feb 15.

  PMID: 29945726 BACKGROUND

• World Health Organization. Fragility fractures [Internet]. Geneva: World Health Organization; 2024 [cited 2026 Jun 23]. Available from: https://www.who.int/news-room/fact-sheets/detail/fragility-fractures.

  BACKGROUND

• Giangregorio LM, Papaioannou A, Macintyre NJ, Ashe MC, Heinonen A, Shipp K, Wark J, McGill S, Keller H, Jain R, Laprade J, Cheung AM. Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27.

  PMID: 24281053 BACKGROUND

• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.

  PMID: 30703272 BACKGROUND

• Bohannon RW. Grip Strength: An Indispensable Biomarker For Older Adults. Clin Interv Aging. 2019 Oct 1;14:1681-1691. doi: 10.2147/CIA.S194543. eCollection 2019.

  PMID: 31631989 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, randomized, parallel-assignment model. Eligible participants were individually randomized after baseline assessment to one of two concurrent groups: a supervised progressive strength and balance exercise program or a home-based conventional exercise program. Both groups were followed for 6 months, and no crossover or factorial assignment was planned.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
• Access Criteria: Data will be shared with qualified researchers who submit a methodologically sound research proposal for secondary analyses, systematic reviews, meta-analyses, or research related to osteoporosis, falls, rehabilitation, exercise therapy, balance, or functional outcomes. Requests will be reviewed by the corresponding author and will be subject to institutional approval. Approved researchers will be required to sign a data use agreement and agree to use the data only for the approved purpose, maintain confidentiality, not attempt to reidentify participants, and not share the data with third parties.

Locations

ME (1)