Comparison the effect of Physical Activity Programs on Physiological and Behavioral Responses, Motor Performance and Neuromuscular Development in preterm Infants: Single blind Randomized Clinical Trial
This study is a single blind clinical trial in order to compare the effect of physical activity programs on physiological and behavioral responses, motor performance and neuromuscular development in preterm infants. A population of preterm neonates with 26-30 weeks of gestational age and birth weight at least 800 g admitted to the medical center Alzahra of Tabriz, is studied. The present study will do during the 32 weeks. Sample size will be 72 persons. Infants will be randomly divided to 4 groups: Physiotherapy, Hydrotherapy, Combination and Holding (Containment). The program duration is 14 days. The physical activity program’s¬ was based on the Meyer-Miller protocol. Briefly, this protocol involves extension and flexion, range of motion exercise with passive resistance of both the upper and lower extremities (total 12 sessions). On every week will be considered a day of rest. In the hydrotherapy group, the researcher will be done semi-circular movements in the pelvic area while the head and neck will constant and then semi-circular motions will performed in the head and neck while the pelvis will be constant. Each session will be 10 minutes and carried out 7 sessions every other day. Combination group, every other day will be done physiotherapy and hydrotherapy. In Holding group, the researcher will be kept baby for at least 15 minutes daily once on fetus state (hands in the mid-line and legs tucked on the abdomen). Physiological and behavioral responses of infants will be measured during and 10 minutes before and after the interventions. Infant’s behavioral responses will be evaluated by the Neonatal Individual Development Care and Assessment Program group analyzers. Motor performance by Test of infant motor performance and neuromuscular evolution evaluate with selected items from the Dubowitz and NEW BALLAR scales.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405208315N7
Registration date:2014-08-25, 1393/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-25, 1393/06/03
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-08-16, 1393/05/25
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Physical Activity Programs on Physiological and Behavioral Responses, Motor Performance and Neuromuscular Development in preterm Infants: Single blind Randomized Clinical Trial
Public title
The effect of physical activity on Physiological and Behavioral Responses, Motor performance and Neuro-mascular Development
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Gestational age 26-30 weeks; Post conception age 32 weeks; Birth weight at least 800 gram; Weight the studying time 1000-2000 gr; Appropriate Gestational age; APGAR scores more than 7; Mother has not drug abuse; Infant isn't IUGR; Infant has a Positive history of mechanical ventilation(Mechanical ventilation, CPAP, Oxyhood) at least for 3 days and use of sedative drug; Infant has not any medicine and metabolic disorders; Absence of neurological anomalies, congenital and chromosomal abnormalities. Exclusion Criteria: Delayed diagnosis of neural anomalies, Congenital and chromosomal abnormalities at 32 to 34 weeks; Severe infection and diseases require to surgery and photo-therapy at 32 to 34 weeks; Physiological instability during the program, as HR more than 180 or HR less than 100 and SaO2 drops to less than 88% twice a day during the intervention (Particularly during the Hydrotherapy); Diagnosis the cardiovascular and musculoskeletal diseases, hip dislocation and Erb Duchenne paralysis during the study; Transfer to another facility during the intervention.
Age
From 7 days old to 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
South Shariati Ave. Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947979
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
9360
Health conditions studied
1
Description of health condition studied
1-Preterm Infant 2- low birth weight
ICD-10 code
p07 ,p07.1
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified. 2-Other low birth weight
1-motor performance 2- neuromuscular developmental of Joint of Wrists, Elbows, Shoulders, Ankles, Knees, Thighs
Timepoint
1-Before the first session and after the last session of the intervention. 2-Before the first session and after the last session of the intervention.
Method of measurement
1- Test of Infant Motor Performance (TIMP) 2-Selected items from Neuromuscular maturity NEW Ballard and Dubowitz scales
Intervention groups
1
Description
1-The physical activity program wil be based on the Moyer-Mileur protocol. Then repetitions of each movement were performed on the Wrists, Elbows, Shoulders, Ankles, Knees and Hips joints. The sequence was performed slowly and in the cephalocaudal direction, with an average of six movements per min, and in the following sequence: right arm, left arm, right leg, left leg and, finally, simultaneous movements on both legs.¬ Intervention will be done for a total of 15 min.
2- Hydrotherapy activity will be done semi-circular movements in the pelvic area while the head and neck will constant and then semi-circular motions will performed in the head and neck while the pelvis will be constant. Intervention will be done for a total of 10 min.
3- Containment include putting the infant in fetal position (feet gathered on the abdomen and head bent the chest). Baby will be hold Daily once for 15 minutes.
Category
Rehabilitation
2
Description
Holding group’s :The researcher will be kept baby in fetal position to support the head¬, neck and extremities (the bent in the midline) for 15 min, once daily.
Category
Rehabilitation
3
Description
Hydrotherapy groups: semi rotational movements of the head and neck will be doing while pelvic area is constant and then semi rotational movements of the pelvic will be doing while the head and upper parts are constant , it will run during 10 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Therapeutic Center Al-Zahra
Full name of responsible person
Leila Valizadeh
Street address
Tabriz, South Artesh Street, Bagh Shomal Cross, Al Zahra Hospital
City
Tabriz
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Leila Valizadeh
Street address
South Shariati Street- Nursing and Midwifery faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Azadi Street, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz nursing and midwifere faculty
Full name of responsible person
mahnaz sanaeifar
Position
Master Science Student of neonatal intensive care
Other areas of specialty/work
Street address
South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 44 3623 0217
Fax
+98 47 52839
Email
maha.sanaeifar@yahoo.com
Web page address
www.tbzmed.ac.ir.
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Valizadeh
Position
Professor assistant
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 47 52839
Email
valizadehl@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir.
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Sanaeifar
Position
MS nursing student
Other areas of specialty/work
Street address
south shariati st., Tabriz Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 47 52839
Email
maha.sanaeifar@yahoo.com
Web page address
www.tbzmed.ac.ir.
Sharing plan
Deidentified Individual Participant Data Set (IPD)