Physical Therapy to Prevent Osteopenia in Preterm Infants

NCT04356807 | Completed

• 1 other identifier: Fisio-Osteopenia
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Metabolic Bone Disease

Keywords

Premature Infant; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• Change in Serum biomarkers of osteocalcin markers

  osteocalcin markers

  Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

• 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)

• 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 Outcomes (3)

• Change in Height

  Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

• Change in Weight

  Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

• Change in Head circumference

  Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

Study Arms (3)

Reflex Locomotion Therapy

EXPERIMENTAL

during 15 minutes once a day five days a week

Procedure: Reflex Locomotion Therapy

Passive Joint Mobilizations

EXPERIMENTAL

during 15 minutes once a day five days a week

Procedure: Passive Joint Mobilizations

Massage

PLACEBO COMPARATOR

during 15 minutes once a day five days a week

Procedure: Massage

Interventions

Reflex Locomotion Therapy PROCEDURE

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.

Reflex Locomotion Therapy

Passive Joint Mobilizations PROCEDURE

Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008

Passive Joint Mobilizations

Massage PROCEDURE

Soft massage with soft pressures in limbs, tactile stimulation and no motion.

Massage

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants
• 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.

You may not qualify if:

• Neurological disorders
• Mechanical ventilation
• Bronchopulmonary dysplasia
• Congenital malformations
• Metabolic diseases
• Genetic diseases
• Intraventricular hemorrhage III-IV,
• Diuretic medication or corticosteroids

Sponsors & Collaborators

• Galaad Torró Ferrero: lead

Study Sites (3)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Torrecárdenas de Almería

Almería, 04009, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Related Publications (9)

• 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.

  PMID: 18633420 BACKGROUND

• 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.

  PMID: 22773291 BACKGROUND

• 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.

  PMID: 7562289 BACKGROUND

• 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.

  PMID: 29242413 BACKGROUND

• 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.

  PMID: 20868518 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29595683 BACKGROUND

• 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.

  PMID: 35804078 DERIVED

• 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.

  PMID: 35739544 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Galaad Torró-Ferrero, MSc

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care Provider and Outcomes Assessor are masked to the objectives of the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 22, 2020
• Study Start: February 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: indefinitive
• Access Criteria: Data will be shared after contacting the authors under reasonable request

Locations

ES (3)