Physical Therapy to Prevent Osteopenia in Preterm Infants

Metabolic Bone Disease Clinical Trial

Official title:

Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356807
• Other study ID #: Fisio-Osteopenia
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2020

Study information

• Verified date: November 2020
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether reflex locomotion therapy is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods like passive joint mobilizations and massage

Description:

Premature infants have smaller and low bone mineralization compared with term infants bones, since 80% of calcium uptake occurs at the end of pregnancy. Passive Physiotherapy has been effective in the treatment of osteopenia. Active mobilizations implemented by the baby itself, may be more effective than passive, as they cause muscle contraction from the Central Nervous System (CNS). Reflex locomotion therapy (RLT), stimulates CNS causing muscle contraction so it may be effective in the treatment of osteopenia in premature.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants

• 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:

• Neurological disorders

• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Torrecárdenas de Almería	Almería
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Galaad Torró Ferrero

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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.

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. — View Citation

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. — View Citation

Sanz-Esteban I, Calvo-Lobo C, Ríos-Lago M, Álvarez-Linera J, Muñoz-García D, Rodríguez-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tibial Speed of Sound	In order to measure bone mineralization, we used the tibial sound velocity test, using for that purpose a quantitative ultrasound device. It was measured on the left tibia in its lower third, while keeping the knee flexed at a 90 degree angle. The measurement point was made perpendicular to the direction of the bone. Three to five consecutive measurements were made, after which the average of these measurements was calculated to have one unique measure in m/s.	Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Primary	Change in Serum biomarkers of Bone-specific phosphatase markers	N-telopeptides from collagen bonds from serum	Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Primary	Change in Serum biomarkers of osteocalcin markers	osteocalcin markers	Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Primary	Change in Serum biomarkers of Beta-cross Laps.	Beta-cross Laps.	Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Primary	Change in Urine biomarkers of N-telopeptides from collagen bonds	N-telopeptides from collagen bonds	Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Secondary	Change in Height	For anthropometry, height in cm were collected	Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Secondary	Change in Weight	measurements of weight in grams were collected	Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Secondary	Change in Head circumference	For anthropometry, measurements of head circumference in cm were collected	Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)