The application of near infrared spectroscopy during exercise and recovery in children with dermatomyositis: a pilot study.

The application of near infrared spectroscopy during exercise and recovery in children with dermatomyositis: a pilot study. - Near infrared spectroscopy in juvenile dermatomyositis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34183

Enrollment

Registered

2011-02-23

Start date

2011-03-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'Juvenile dermatomyositis'

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Juvenile dermatomyositis patients: diagnose juvenile dermatomyositis; age between 8 and 18 years; informed consent signature by (the children and) the parents/caregivers. Juvenile idiopathic arthritis patients: diagnose juvenile idiopathic arthritis; age between 8 and 18 years; informed consent signature by (the children and) the parents/caregivers. Healthy control subjects: healthy; age between 8 and 18 years; informed consent signature by (the children and) the parents/caregivers.

Exclusion criteria

Exclusion criteria: Juvenile dermatomyositis patients: Diagnose polymyositis or myositis Age = 18 years Medical status that will not allow exercise testing Insufficient understanding of the Dutch language in both children and parents/caregivers No informed consent;Juvenile idiopathic arthritis patients: Age = 18 years Medical status that will not allow exercise testing Insufficient understanding of the Dutch language in both children and parents/caregivers No informed consent;Healthy control subjects: Age = 18 years Muscle disease in history Chronic medication intake Underlying auto-immune diseases Medical status that will not allow exercise testing Insufficient understanding of the Dutch language in both children and parents/caregivers No informed consent

Design outcomes

Primary

Measure	Time frame
The following main study parameters will be continuously determined with NIRS in the VM and VL muscle of the dominant leg: - Change in concentration deoxygenated hemoglobin (µM) - Change in concentration oxygenated hemoglobin (µM) - Change in concentration total hemoglobin (µM) - Change in concentration deoxygenated hemoglobin minus change in concentration oxygenated hemoglobin (µM) The following study parameters are sole values that will be determined from the CPET: - Relative peak oxygen consumption as percentage of predicted (%) - Ventilatory anaerobic threshold as percentage of predicted relative peak oxygen consumption (%) - Peak power output as percentage of predicted (%) - Oxygen uptake to work rate slope (ml O2 /Watt) The T1/2 (s) will be determined from the change in oxygenated hemoglobin concentration data from the VM and VL muscle of the dominant leg in the recovery phase.	—

Measure

Time frame

The following main study parameters will be continuously determined with NIRS in the VM and VL muscle of the dominant leg: - Change in concentration deoxygenated hemoglobin (µM) - Change in concentration oxygenated hemoglobin (µM) - Change in concentration total hemoglobin (µM) - Change in concentration deoxygenated hemoglobin minus change in concentration oxygenated hemoglobin (µM) The following study parameters are sole values that will be determined from the CPET: - Relative peak oxygen consumption as percentage of predicted (%) - Ventilatory anaerobic threshold as percentage of predicted relative peak oxygen consumption (%) - Peak power output as percentage of predicted (%) - Oxygen uptake to work rate slope (ml O2 /Watt) The T1/2 (s) will be determined from the change in oxygenated hemoglobin concentration data from the VM and VL muscle of the dominant leg in the recovery phase.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results