The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants

TC Erciyes University

Status: Completed

Conditions: Osteopenia of Prematurity

Treatments: Procedure: Daily Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03773679

2016/282

Details and patient eligibility

About

ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.

Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.

Full description

Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.

Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.

Enrollment: 24 patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Inclusion criteria for the infants were as follows:

• postnatal age of 1-5 days,
• gestational age of 28-32 weeks,
• birth weight of 1,000-1,500 gr,
• no diagnosis of necrotizing enterocolitis (NEC), digestive system or chromosomal abnormalities, skin diseases, intrauterine growth retardation (IUGR), SGA, and large gestational age (LGA),
• no history of surgical intervention, and
• no medical treatment except for appropriate vitamin supplements and antibiotic treatments.

Exclusion Criteria:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Exercise Group

Experimental group

Description:

Daily exercise program involved "Range of Motion (ROM) exercises against extremity resistances" and "extension and flexion in upper and lower extremities." Exercises were implemented on wrists, elbows, shoulders, ankles, knees, and hip joints of the infants by the same researcher (YSE). The daily exercise program was repeated 5-8 times, 1 session/day (a similar time of the day), for 30 days. Each session continued for 7-10 minutes.

Treatment:

Procedure: Daily Exercise

Control Group

No Intervention group

Description:

The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.