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Efficacy and Safety of the Physical Activity Program in Women With Post-menopausal Osteoporosis

NCT04179903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-09-26

No results posted yet for this study

Summary

The study will be single blinded since professionals who will evaluate patients will not know to which exercise group patients have been assigned.

The investigators hypothesize that effectiveness and safety of the exercise program are equal when administered as gym trainer or individual home trainer. However, the investigators expect differences in adherence among the two groups which may cause different impact on the outcome measures.

Given the large amount of evidence on the efficacy of Physical Activity in women with Osteoporosis, the investigators considered it ethically unacceptable to advise a control group inactivity. On the other hand, it seemed particularly relevant for the purpose of addressing the advice to the improvement of the active lifestyle, to evaluate the impact of the ACTLIFE exercise program when administered as gym trainer or individual home trainer

Conditions

  • Osteoporosis, Postmenopausal
  • Physical Activity

Interventions

OTHER

Physical activity

Physical Activity program is performed in a group in a gym and at home

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Claudio Ripamonti · IOR

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-09-30
Completion
2021-06-30

Countries

  • Italy

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 NCT04179903 on ClinicalTrials.gov