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NCT04179903: ACTLIFE

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

Completed NA Last updated 26 September 2023
What this trial tests

NA trial testing Physical activity in Osteoporosis, Postmenopausal in 52 participants. Completed in 30 June 2021.

Timeline
1 February 2019
Primary endpoint
30 September 2020
30 June 2021

Quick facts

Lead sponsorIstituto Ortopedico Rizzoli
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment52
Start date1 February 2019
Primary completion30 September 2020
Estimated completion30 June 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

40 and older, female only, with Osteoporosis, Postmenopausal or Physical Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol.
    Bragonzoni L, Barone G, Benvenuti F, Canal V, et al · · 2020 · cited 7× · PMID 32012966 · DOI 10.3390/ijerph17030809
  2. Influence of Coaching on Effectiveness, Participation, and Safety of an Exercise Program for Postmenopausal Women with Osteoporosis: A Randomized Trial.
    Bragonzoni L, Barone G, Benvenuti F, Ripamonti C, et al · · 2023 · cited 4× · PMID 36777456 · DOI 10.2147/cia.s389967
  3. Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis.
    Pinelli E, Barone G, Marini S, Benvenuti F, et al · · 2021 · cited 4× · PMID 33801389 · DOI 10.3390/ijerph18052441

Verify or expand the search:

Other trials of Physical activity

Trials testing the same drug.

Other recruiting trials for Osteoporosis, Postmenopausal

Currently open trials in the same condition.

Other Istituto Ortopedico Rizzoli trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04179903.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing