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

NCT03773679 | Completed

• 1 other identifier: 2016/282
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteopenia of Prematurity

Keywords

Preterm infants with very low birth weight (VLBW); bone mineral density; cortisol; exercise

Outcome Measures

Primary Outcomes (1)

• Bone speed of sound values

  To measure SOS values, the preterm infant was placed on his/her back and his/her right leg was placed to obtain an angle of 900. The middle of the medial malleolus and distal patella apex was found and then gel was poured between the skin and the probe. The probe was put parallel to the bone to contact the point determined to be in the middle of the tibia and was moved from inside the leg. Afterward, the probe was placed from outside the leg toward the inside. In this study, The SOS from tibia was measured.

  Change from bone speed of sound values at 30 days

Secondary Outcomes (1)

• Serum Cortisol levels

  Change from serum cortisol levels at 30 days

Study Arms (2)

Exercise Group

EXPERIMENTAL

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.

Procedure: Daily Exercise

Control Group

NO INTERVENTION

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

Interventions

Daily Exercise PROCEDURE

Daily Exercise Programme

Exercise Group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Related Publications (1)

• Sezer Efe Y, Erdem E, Gunes T. The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants with Very Low Birth Weight: A Randomized Controlled Trial. J Pediatr Nurs. 2020 Mar-Apr;51:e6-e12. doi: 10.1016/j.pedn.2019.05.021. Epub 2019 Jul 6.

  PMID: 31285069 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Yagmur Sezer Efe

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: April 15, 2016
• Primary Completion: April 15, 2016
• Study Completion: August 31, 2017
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share