An interventional study of Range-of-Motion (ROM) Exercise Program and Standard Neonatal Care in Premature, Very Low Birth Weight Infant and Bone Mineralization, sponsored by Kayseri City Hospital. Completed. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Kayseri City Hospital · Not applicable, Interventional, and Basic science
This randomized controlled study evaluated whether a daily assisted physical activity program affected blood levels of irisin, adiponectin, and C-peptide in very low birth weight preterm infants. The study also assessed changes in growth and measures related to bone health.
Fifty-four clinically stable infants born at 28-32 weeks of gestation, with birth weights of 1,000-1,500 grams, were enrolled at 1-5 days after birth. Infants were randomly assigned to receive either routine neonatal care alone or routine care plus gentle assisted movements of the arms and legs. The activity program was delivered by a trained practitioner for 7-10 minutes once daily for 30 consecutive days.
Blood markers, body measurements, and bone ultrasound measurements were assessed at baseline and after 30 days to compare changes between the groups.
Study Design This randomized controlled study included preterm infants allocated to either an exercise (intervention) group or a control group. Eligible preterm infants were assigned to study groups using a computer-generated simple randomization method. Allocation was performed after eligibility assessment by the attending neonatologist. Very low birth weight (VLBW) preterm infants in the intervention group received a daily assisted physical activity program for 30 consecutive days, while infants in the control group received standard neonatal care without additional intervention.
Due to the nature of the intervention, it was not possible to blind the specialist implementing the physical activity program. However, to minimize assessment and detection bias, parents, the neonatologist, data collectors, and laboratory staff performing the biochemical analyses were kept unaware of the group assignment. Written informed consent was obtained from the parents or legal guardians of all participating infants prior to enrollment.
Infants who developed clinical deterioration during the intervention period, including respiratory distress or the need for mechanical ventilation, were excluded from the study to ensure patient safety.
Sample Size Estimation Because the present trial had been completed before the publication of the subsequently available reference data, a retrospective assessment of sample size adequacy was performed using effect-size estimates reported in comparable studies. Using G*Power, with a two-sided α of 0.05 and 80% power, an effect size of approximately Cohen's d = 0.80 for irisin corresponded to a required total sample of approximately 52 participants. The final analytic sample included 52 infants (27 in the exercise group and 25 in the control group).
Eligibility Criteria Preterm infants were eligible for inclusion if they met the following criteria: postnatal age between 1 and 5 days, gestational age between 28 and 32 weeks, birth weight between 1000 and 1500 g, and clinical stability at enrollment. Infants were excluded if they had necrotizing enterocolitis (NEC), gastrointestinal or chromosomal anomalies, intrauterine growth restriction (IUGR), were small or large for gestational age (SGA or LGA), had skin diseases, had undergone surgical intervention, or were receiving medical treatment other than routine vitamin supplementation and antibiotic therapy.
Randomization and Allocation Concealment Eligible infants were randomly allocated to either the exercise group (n = 27) or the control group (n = 27) using a computer-generated block randomization sequence (block size = 2). The randomization sequence was prepared by an independent researcher not involved in participant selection, intervention delivery, or outcome assessment. Allocation concealment was maintained through a centralized randomization method. No stratification was applied. During the follow-up period, two participants in the control group were withdrawn due to missing outcome measurements, resulting in a final analyzed sample of 52 infants (exercise: n = 27; control: n = 25). Participant flow is presented in the CONSORT flow diagram (Figure 1). A completed CONSORT 2010 checklist is provided as Online Supplementary Material, as required by the journal for reports of randomized controlled trials.
Ethical Considerations Ethical approval was obtained from the Erciyes University Faculty of Medicine Ethics Committee (Approval date: April 15, 2016; Decision No: 2016/282). Institutional permission was granted by Erciyes University Faculty of Medicine Hospitals (Approval date: February 22, 2016; Reference No: 2016/282). Written informed consent was obtained from the parents or legal guardians of all participating infants prior to enrollment. This study was conducted in accordance with the principles of the Declaration of Helsinki.
Intervention Exercise Group VLBW preterm infants in the exercise group received a daily assisted physical activity program based on the protocol described by Moyer-Mileur et al. (2000). The program consisted of range-of-motion (ROM) exercises against gentle resistance and flexion-extension movements of the upper and lower extremities, applied bilaterally to the wrists, elbows, shoulders, ankles, knees, and hip joints by the same trained practitioner. The intervention was administered once daily at approximately the same time each day for 30 consecutive days. Each session included 5-8 repetitions per joint, with a mean session duration of 7-10 minutes.
Control Group Preterm infants in the control group received standard neonatal care according to routine clinical practice and did not undergo any additional physical activity or exercise intervention during the study period.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 54 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Kayseri City Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Exercise Group): Very low birth weight (VLBW) preterm infants received a daily assisted physical activity program based on the Moyer-Mileur protocol. The program consisted of range-of-motion (ROM) exercises against gentle resistance and flexion-extension movements of the upper and lower extremities, applied bilaterally to the wrists, elbows, shoulders, ankles, knees, and hip joints. The intervention was administered once daily for 30 consecutive days, with a mean session duration of 7-10 minutes (5-8 repetitions per joint).
Behavioral: Range-of-Motion (ROM) Exercise Program
Control Group): Preterm infants received standard neonatal care according to routine clinical practice. They did not undergo any additional physical activity or exercise interventions during the study period.
Other: Standard Neonatal Care
The intervention is a daily assisted physical activity program based on the protocol described by Moyer-Mileur et al.. The program consists of range-of-motion (ROM) exercises against gentle resistance and flexion-extension movements of the upper and lower extremities. These exercises are applied bilaterally to the wrists, elbows, shoulders, ankles, knees, and hip joints by the same trained practitioner. The intervention is administered once daily at approximately the same time each day for 30 consecutive days. Each session includes 5 to 8 repetitions per joint, with a mean session duration of 7 to 10 minutes.
Routine clinical practice for preterm infants in the neonatal intensive care unit.
Change in Serum Irisin Concentration
Serum irisin levels are quantitatively measured using an enzyme-linked immunosorbent assay (ELISA). The results are expressed in ng/mL.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Adiponectin Concentration
Serum adiponectin levels are quantitatively measured using an enzyme-linked immunosorbent assay (ELISA). The results are expressed in ng/mL.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum C-peptide Concentration
Serum C-peptide levels are quantitatively measured using an enzyme-linked immunosorbent assay (ELISA). The results are expressed in pg/mL.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Bone Speed of Sound (SOS)
Bone speed of sound (SOS) is assessed as an indicator of bone strength and mineralization using quantitative ultrasound.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Body Weight
Change in body weight measured using a digital scale from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Calcium Concentration
Change in serum calcium concentration from baseline to the end of the 30-day intervention period, assessed as a marker of bone metabolism.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Body Length
Change in body length from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Head Circumference
Change in head circumference from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Chest Circumference
Change in chest circumference from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Abdominal Circumference
Change in abdominal circumference from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Tibial Length
Change in tibial length from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Mid-Upper Arm Circumference
Change in mid-upper arm circumference from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Triceps Skinfold Thickness
Change in triceps skinfold thickness measured using a skinfold caliper from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Phosphorus Concentration
Change in serum phosphorus concentration from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Magnesium Concentration
Change in serum magnesium concentration from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Alkaline Phosphatase (ALP)
Change in serum alkaline phosphatase (ALP) from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Serum Parathyroid Hormone (PTH)
Change in serum parathyroid hormone (PTH) from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Urinary Calcium Level
Change in urinary calcium level from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Urinary Phosphorus Level
Change in urinary phosphorus level from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
Change in Urinary Magnesium Level
Change in urinary magnesium level from baseline to the end of the 30-day intervention period.
Time frame: Baseline (Day 0) and post-intervention (Day 30)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly due to the highly sensitive nature of the medical data collected from a vulnerable population (preterm infants in the neonatal intensive care unit) and strict institutional patient privacy regulations.
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Jan 2017, 9 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 9 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital