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

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ClinicalTrials.gov Identifier: NCT03773679
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yağmur Sezer Efe, TC Erciyes University

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.


Condition or disease Intervention/treatment Phase
Osteopenia of Prematurity Procedure: Daily Exercise Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : April 15, 2016
Actual Study Completion Date : August 31, 2017


Arm Intervention/treatment
Experimental: Exercise Group
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
Daily Exercise Programme

No Intervention: Control Group
The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.



Primary Outcome Measures :
  1. Bone speed of sound values [ Time Frame: Change from bone speed of sound values at 30 days ]
    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.


Secondary Outcome Measures :
  1. Serum Cortisol levels [ Time Frame: Change from serum cortisol levels at 30 days ]
    serum biochemical parameters



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Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773679


Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Yagmur Sezer Efe TC Erciyes University

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Responsible Party: Yağmur Sezer Efe, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03773679     History of Changes
Other Study ID Numbers: 2016/282
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yağmur Sezer Efe, TC Erciyes University:
Preterm infants with very low birth weight (VLBW)
bone mineral density
cortisol
exercise

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents