Physical Therapy to Prevent Osteopenia in Preterm Infants
NCT ID: NCT04356807
Last Updated: 2025-04-25
Study Results
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Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2016-02-29
2020-07-31
Brief Summary
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Detailed Description
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Objectives: To determine whether RLT is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods.
Methodology: Our study is a multicentre randomized clinical trial, with 90 children less than 34 weeks of gestational age, divided into three treatment groups, one will receive RLT, another will be treated with passive joint mobilizations with articular pressure; and last one will be done massage techniques. The treatment will last for one month, for the three groups. We intend to measure changes in mineralization, bone formation, and bone resorption, and anthropometry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Reflex Locomotion Therapy
during 15 minutes once a day five days a week
Reflex Locomotion Therapy
The exercises corresponding to the motor complexes of the 1st phase of the rolling reflex and the original creeping reflex were performed, dedicating one minute to each side and performing two repetitions in each session.
Passive Joint Mobilizations
during 15 minutes once a day five days a week
Passive Joint Mobilizations
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
Massage
during 15 minutes once a day five days a week
Massage
Soft massage with soft pressures in limbs, tactile stimulation and no motion.
Interventions
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Reflex Locomotion Therapy
The exercises corresponding to the motor complexes of the 1st phase of the rolling reflex and the original creeping reflex were performed, dedicating one minute to each side and performing two repetitions in each session.
Passive Joint Mobilizations
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
Massage
Soft massage with soft pressures in limbs, tactile stimulation and no motion.
Eligibility Criteria
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Inclusion Criteria
* 26 to 34 weeks of gestational age
* Admitted in neonates
* Hemodynamically stable
* Complete enteral nutrition
* Parents or guardians signed an informed consent authorizing the participation of the baby in this study.
Exclusion Criteria
* Mechanical ventilation
* Bronchopulmonary dysplasia
* Congenital malformations
* Metabolic diseases
* Genetic diseases
* Intraventricular hemorrhage III-IV,
* Diuretic medication or corticosteroids
* Bone fractures at the time of inclusion.
34 Weeks
ALL
No
Sponsors
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Galaad Torró Ferrero
OTHER
Responsible Party
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Galaad Torró Ferrero
Principal Investigator
Principal Investigators
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Galaad Torró-Ferrero, MSc
Role: PRINCIPAL_INVESTIGATOR
Universidad de Murcia
Locations
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Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Torrecárdenas de Almería
Almería, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Countries
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References
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Vignochi CM, Miura E, Canani LH. Effects of motor physical therapy on bone mineralization in premature infants: a randomized controlled study. J Perinatol. 2008 Sep;28(9):624-31. doi: 10.1038/jp.2008.60. Epub 2008 Jul 17.
Vignochi CM, Silveira RC, Miura E, Canani LH, Procianoy RS. Physical therapy reduces bone resorption and increases bone formation in preterm infants. Am J Perinatol. 2012 Sep;29(8):573-8. doi: 10.1055/s-0032-1310520. Epub 2012 Jul 6.
Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.
Shaw SC, Sankar MJ, Thukral A, Natarajan CK, Deorari AK, Paul VK, Agarwal R. Assisted Physical Exercise for Improving Bone Strength in Preterm Infants Less than 35 Weeks Gestation: A Randomized Controlled Trial. Indian Pediatr. 2018 Feb 15;55(2):115-120. Epub 2017 Dec 14.
Giannantonio C, Papacci P, Ciarniello R, Tesfagabir MG, Purcaro V, Cota F, Semeraro CM, Romagnoli C. Chest physiotherapy in preterm infants with lung diseases. Ital J Pediatr. 2010 Sep 26;36:65. doi: 10.1186/1824-7288-36-65.
El-shaarawy MK, Rahman SAA, Fakher M, El A, Salah WM. Effect of rolling on oxygen saturation and incubation period in preterm neonates with respiratory distress syndrome. Int J Dev Res. 2017;07(01):11319-11323.
Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.
Torro-Ferrero G, Fernandez-Rego FJ, Aguera-Arenas JJ, Gomez-Conesa A. Effect of physiotherapy on the promotion of bone mineralization in preterm infants: a randomized controlled trial. Sci Rep. 2022 Jul 8;12(1):11680. doi: 10.1038/s41598-022-15810-6.
Torro-Ferrero G, Fernandez-Rego FJ, Jimenez-Liria MR, Aguera-Arenas JJ, Pinero-Penalver J, Sanchez-Joya MDM, Fernandez-Berenguer MJ, Rodriguez-Perez M, Gomez-Conesa A. Effect of physical therapy on bone remodelling in preterm infants: a multicenter randomized controlled clinical trial. BMC Pediatr. 2022 Jun 24;22(1):362. doi: 10.1186/s12887-022-03402-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Fisio-Osteopenia
Identifier Type: -
Identifier Source: org_study_id
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