search
Back to results

Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants

Primary Purpose

Osteopenia Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physical exercise group
Control group
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteopenia Prematurity

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures);
  • Birth weight ≤ 1.500gm;
  • Body size appropriate for gestational age;
  • Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity;
  • Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d.
  • Not requiring oxygen or mechanical ventilation at the start of the exercise protocol.

Exclusion Criteria:

  • Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts);
  • Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.);
  • Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis;
  • Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life

Sites / Locations

  • Ain shams university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

physical exercise group

Control group

Arm Description

For the exercise group, Intervention by doing physical exercise. systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital.

Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control

Outcomes

Primary Outcome Measures

serum calcium
mg/dL
serum PO4
mg/dL
serum magnesium
mg/dL
ALP
IU/L
CTX
pg/mL
Whole body BMD
mg/cm2

Secondary Outcome Measures

Full Information

First Posted
March 19, 2016
Last Updated
May 4, 2018
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT03354988
Brief Title
Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
Official Title
Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to assess whether physical activity programs in preterm infants improve bone mineralization as well as growth and reduce the risk of fractures. The secondary aim is to include other potential benefits in terms of length of hospital stay, weaning from mechanical ventilation, feeding tolerance and adverse events
Detailed Description
This is a prospective randomized controlled clinical trial that will be conducted on 36 VLBW preterm infants admitted to the neonatal intensive care unit (NICU) - Ain Shams University METHODS: All the newborns included in the study will be subjected to the following: Comprehensive history taking including: Antenatal history: Maternal age, maternal diseases, maternal diabetic control, maternal infection (STORCH infection), maternal medication during this pregnancy, and last menstrual period. Natal history: Gestational age, neonatal sex and mode of delivery. Postnatal history: Respiratory distress and cyanosis. Family history: Consanguinity, congenital anomalies, previous abortion, sibling death, and still birth. Thorough clinical examination with particular emphasis on: Assessment of Apgar scores at 1 and 5 minutes Assessment of gestational age based on last menstrual period and confirmed by ultrasonography in early pregnancy if possible and Ballard scores Complete examination including cardiac, chest, abdominal, and neurological examination. Sample size calculation and Randomization: The sample size was calculated using power and sample size calculation program and was based on the previously reported intervention changes in Bone mineral density (BMD) following assisted exercise. A mean difference of 5.3 mg cm2 between the groups, with a standard deviation of 5.6 mg cm2 was used, based on the study by Considering a 0.05 significance level and power equal to 80%, an n of 19 patients per group was determined. Patients who will meet the inclusion criteria will be randomized into the physical exercise (n=18) and control (n=18) groups. Randomization will be made by birth order; the first born preterm infant will be recruited to the exercise group, the second to the control group, etc. Standard neonatal care: Babies admitted to NICU bathed, placed in incubator, attached to monitor. Cannula inserted, IV fluids is started (Dexstrose10%) and IV antibiotics. If there is respiratory distress: O2 or ventilation is started, usually feeds are delayed to day 2 or day 3 (or even later) according the severity of condition (clinical decision according to the attending neonatologist). If no distress and the baby is well: trophic feeds is started (10ml/kg/day milk), feeds is increased in 10-20ml/kg/day according to baby tolerance, and the condition of the baby (clinical decision according to the attending neonatologist), IV fluids are reduced gradually. Exercise protocol: The exercise protocol was designed for Infants in treatment and control groups received well defined interventions applied by the same trained occupational therapist, described as follows: For the exercise group, systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital. Because tactile stimulation might have influenced growth and development, control subjects had a daily interactive period of holding and stroking but no range-of-motion activity. The time schedule of each activity was the same as the exercise group. Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control and exercise group subjects according to the neonatal intensive care unit (NICU) recommendations, however, without movement and standardized articular compression. Laboratory investigation: Complete blood count with differential leucocytic count. Serum calcium concentration. Serum phosphorous concentration. Serum magnesium concentration. Serum alkaline phosphates concentration. Serum Alanine Aminotransferase (ALT). Serum carboxy-terminal cross linked telopeptides of type 1 collagen (CTX). Urinary calcium/phosphorous ratio. All the previous investigations will be done before at after the end of the exercise protocol for patients and control groups. Bone mineralization will be assessed by measured by dual- energy x- ray absorptiometry (DEXA) : DEXA evaluates body composition (total body will be done after the end of the exercise protocol for patients and control groups by measuring: Bone mineral Content (BMC, mg), Bone Mineral Density (BMD, mg/ cm2), Bone area (BA/ cm2), Lean mass (LM, g) and Fat mass (g). Ethical Considerations: Collected data will be used for study purpose only. The mothers of the newborns under study will be informed about the purpose of the study and the plan of work before agreeing to participate. They will be provided informed consent before the testing began. Study protocol will be presented to and approved by the Ethical Committee of the Scientific Research-Ain Shams University.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia Prematurity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
physical exercise group
Arm Type
Active Comparator
Arm Description
For the exercise group, Intervention by doing physical exercise. systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital.
Arm Title
Control group
Arm Type
Other
Arm Description
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
Intervention Type
Other
Intervention Name(s)
Physical exercise group
Intervention Description
For the exercise group, systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
Primary Outcome Measure Information:
Title
serum calcium
Description
mg/dL
Time Frame
2 weeks
Title
serum PO4
Description
mg/dL
Time Frame
2 weeks
Title
serum magnesium
Description
mg/dL
Time Frame
2 weeks
Title
ALP
Description
IU/L
Time Frame
2 weeks
Title
CTX
Description
pg/mL
Time Frame
2 weeks
Title
Whole body BMD
Description
mg/cm2
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures); Birth weight ≤ 1.500gm; Body size appropriate for gestational age; Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity; Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d. Not requiring oxygen or mechanical ventilation at the start of the exercise protocol. Exclusion Criteria: Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts); Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.); Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis; Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rania elfarrash, assprofessor
Organizational Affiliation
Ain Shams univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams university hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants

We'll reach out to this number within 24 hrs