Physical Therapy to Prevent Osteopenia in Preterm Infants
Primary Purpose
Metabolic Bone Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Reflex Locomotion Therapy
Passive Joint Mobilizations
Massage
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Bone Disease focused on measuring Premature Infant, Physical Therapy Modalities
Eligibility Criteria
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.
Sites / Locations
- Hospital General Universitario de Elche
- Hospital Torrecárdenas de Almería
- Hospital Clínico Universitario Virgen de la Arrixaca
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Reflex Locomotion Therapy
Passive Joint Mobilizations
Massage
Arm Description
during 15 minutes once a day five days a week
during 15 minutes once a day five days a week
during 15 minutes once a day five days a week
Outcomes
Primary Outcome Measures
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 in Serum biomarkers of Bone-specific phosphatase markers
N-telopeptides from collagen bonds from serum
Change in Serum biomarkers of osteocalcin markers
osteocalcin markers
Change in Serum biomarkers of Beta-cross Laps.
Beta-cross Laps.
Change in Urine biomarkers of N-telopeptides from collagen bonds
N-telopeptides from collagen bonds
Secondary Outcome Measures
Change in Height
For anthropometry, height in cm were collected
Change in Weight
measurements of weight in grams were collected
Change in Head circumference
For anthropometry, measurements of head circumference in cm were collected
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04356807
Brief Title
Physical Therapy to Prevent Osteopenia in Preterm Infants
Official Title
Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Galaad Torró Ferrero
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Bone Disease
Keywords
Premature Infant, Physical Therapy Modalities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Care Provider and Outcomes Assessor are masked to the objectives of the study
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reflex Locomotion Therapy
Arm Type
Experimental
Arm Description
during 15 minutes once a day five days a week
Arm Title
Passive Joint Mobilizations
Arm Type
Experimental
Arm Description
during 15 minutes once a day five days a week
Arm Title
Massage
Arm Type
Placebo Comparator
Arm Description
during 15 minutes once a day five days a week
Intervention Type
Procedure
Intervention Name(s)
Reflex Locomotion Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Passive Joint Mobilizations
Intervention Description
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
Intervention Type
Procedure
Intervention Name(s)
Massage
Intervention Description
Soft massage with soft pressures in limbs, tactile stimulation and no motion.
Primary Outcome Measure Information:
Title
Change in Tibial Speed of Sound
Description
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.
Time Frame
Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Title
Change in Serum biomarkers of Bone-specific phosphatase markers
Description
N-telopeptides from collagen bonds from serum
Time Frame
Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Title
Change in Serum biomarkers of osteocalcin markers
Description
osteocalcin markers
Time Frame
Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Title
Change in Serum biomarkers of Beta-cross Laps.
Description
Beta-cross Laps.
Time Frame
Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Title
Change in Urine biomarkers of N-telopeptides from collagen bonds
Description
N-telopeptides from collagen bonds
Time Frame
Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Secondary Outcome Measure Information:
Title
Change in Height
Description
For anthropometry, height in cm were collected
Time Frame
Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Title
Change in Weight
Description
measurements of weight in grams were collected
Time Frame
Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Title
Change in Head circumference
Description
For anthropometry, measurements of head circumference in cm were collected
Time Frame
Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galaad Torró-Ferrero, MSc
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Torrecárdenas de Almería
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18633420
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.
Results Reference
background
PubMed Identifier
22773291
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.
Results Reference
background
PubMed Identifier
7562289
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. doi: 10.1016/s0022-3476(95)70127-3.
Results Reference
background
PubMed Identifier
29242413
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.
Results Reference
background
PubMed Identifier
20868518
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
29595683
Citation
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.
Results Reference
background
PubMed Identifier
35804078
Citation
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.
Results Reference
derived
PubMed Identifier
35739544
Citation
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.
Results Reference
derived
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Physical Therapy to Prevent Osteopenia in Preterm Infants
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