NCT07787143

Brief Summary

This prospective, single-group interventional pilot study will evaluate the effects of a 12-week resistance and core stabilization exercise program on bone mineral density and resting muscle oxygenation in male military test pilots with low baseline bone mineral density. Participants will complete a supervised exercise program five days per week for 12 weeks while continuing their routine flight duties. Bone mineral density will be assessed using dual-energy X-ray absorptiometry, and resting muscle oxygenation will be evaluated in the vastus lateralis and rectus abdominis using near-infrared spectroscopy before and after the intervention. The study aims to characterize preliminary skeletal and muscle oxygenation responses to structured exercise in this specialized aviation population.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 11, 2026

Last Update Submit

August 22, 2026

Conditions

Keywords

Military aviationLow bone mineral densityNear-infrared spectroscopyMuscle oxygenationResistance training

Outcome Measures

Primary Outcomes (6)

  • Change in Bone Mineral Density

    BMD will be assessed by DXA at lumbar spine and proximal femoral sites and recorded in g/cm². Change from baseline to 12 weeks will be evaluated. Time Frame: Baseline and 12 weeks

    Baseline and 12 weeks

  • Change in Resting Muscle Oxygen Saturation (SmO₂)

    Resting muscle oxygen saturation will be measured using NIRS in the vastus lateralis and rectus abdominis and reported as percentage (%). Change from baseline to 12 weeks will be evaluated.

    Baseline and 12 weeks

  • Change in Total Haemoglobin (tHb)

    Resting total haemoglobin concentration will be measured using NIRS in the vastus lateralis and rectus abdominis and reported in μM. Change from baseline to 12 weeks will be evaluated.

    Baseline and 12 weeks

  • Change in Oxyhaemoglobin (O₂Hb)

    Resting oxyhaemoglobin concentration will be measured using NIRS in the vastus lateralis and rectus abdominis and reported in μM. Change from baseline to 12 weeks will be evaluated.

    Baseline and 12 weeks

  • Change in Deoxyhaemoglobin (HHb)

    Resting deoxyhaemoglobin concentration will be measured using NIRS in the vastus lateralis and rectus abdominis and reported in μM. Change from baseline to 12 weeks will be evaluated.

    Baseline and 12 weeks

  • Change in Haemoglobin Difference (HbDiff)

    Resting haemoglobin difference will be derived from NIRS measurements in the vastus lateralis and rectus abdominis and reported in μM. Change from baseline to 12 weeks will be evaluated.

    Baseline and 12 weeks

Study Arms (1)

Resistance and Core Stabilization Exercise Program

EXPERIMENTAL

Participants will complete a 12-week supervised resistance and core stabilization exercise program, performed five days per week for approximately 120 minutes per session. The program will progress through three phases: adaptation (weeks 1-4, approximately 60% of one-repetition maximum), strength development (weeks 5-8, 70-75% of one-repetition maximum), and high-load neuromuscular control (weeks 9-12, 80-85% of one-repetition maximum). The intervention will include multi-joint lower-extremity exercises such as squats and deadlifts, core stabilization exercises including planks, side planks, bird-dog, dead bug, and posterior pelvic tilt, and posterior-chain exercises such as lunges, hip thrusts, and back extensions. All sessions will be supervised by a physiotherapist, and training loads will be adjusted according to participant performance and tolerance

Behavioral: Supervised Resistance and Core Stabilization Exercise Program

Interventions

Participants will undergo a 12-week physiotherapist-supervised resistance and core stabilization exercise program performed five days per week for approximately 120 minutes per session. The program will progress through three phases: adaptation (weeks 1-4, approximately 60% of one-repetition maximum \[1RM\]), strength development (weeks 5-8, 70-75% 1RM), and high-load neuromuscular control (weeks 9-12, 80-85% 1RM). The intervention will include multi-joint lower-extremity exercises (squat and deadlift), core stabilization exercises (plank, side plank, bird-dog, dead bug, and posterior pelvic tilt), and posterior-chain exercises (lunges, hip thrusts, and back extensions). Exercise tempo and rest intervals will be standardized, and training loads will be individually adjusted according to participant performance and tolerance

Resistance and Core Stabilization Exercise Program

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male military test pilots with previous military aviation experience Low bone mineral density identified by dual-energy X-ray absorptiometry (DXA) Regular participation in flight duties Medical fitness to participate in regular exercise training Willingness to participate in the 12-week supervised resistance and core stabilization exercise program Ability to provide written informed consent

You may not qualify if:

  • Acute musculoskeletal injury Recent orthopedic surgery Neurological disorder Cardiovascular disease Any medical condition that limits participation in physical exercise Subcutaneous adipose tissue thickness greater than 17.5 mm at the NIRS measurement site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tuesta M, Yanez-Sepulveda R, Verdugo-Marchese H, Mateluna C, Alvear-Ordenes I. Near-Infrared Spectroscopy Used to Assess Physiological Muscle Adaptations in Exercise Clinical Trials: A Systematic Review. Biology (Basel). 2022 Jul 19;11(7):1073. doi: 10.3390/biology11071073.

    PMID: 36101451BACKGROUND
  • Marshall RA, Mandell JC, Weaver MJ, Ferrone M, Sodickson A, Khurana B. Imaging Features and Management of Stress, Atypical, and Pathologic Fractures. Radiographics. 2018 Nov-Dec;38(7):2173-2192. doi: 10.1148/rg.2018180073.

    PMID: 30422769BACKGROUND

Related Links

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Emine Merve ERSEVER, DR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the same 12-week supervised resistance and core stabilization exercise program. Outcomes will be assessed before and after the intervention, with no parallel control or comparison group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

February 15, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share