Calf Muscle Strength in Mitochondrial Diseases

NCT02678637 | Completed DMC

• 1 other identifier: H-1600058
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Mitochondrial disorders are a group of inherited disorders causing malfunctional mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore give symptoms from every tissue, especially those with high energy needs as the brain, heart and muscles. The disorders are highly disabling. The aim of the study is to investigate the relation between muscle strength and contractile cross sectional area (CCSA) in the leg of patients affected by mitochondrial diseases. The hypothesis is that there can be a disrupted relationship between strength and CCSA.

Conditions

Mitochondrial Disease

Keywords

MRI; CCSA; Contractile Cross Sectional Area; Strength; Calf muscle

Outcome Measures

Primary Outcomes (2)

• Muscle CCSA, investigated by Dixon MRI techniques.

  The MRI protocol include a whole body scan. The calf is chosen for qualitative analysis. Cross sectional area is calculated, the amount of adipose tissue is calculated, and the amount of adipose tissue is subtracted from the CSA, giving the CCSA.

  One MRI scan per subject (exam lasts approximately 60 min.)

• Muscle strength, measured as peak torque, investigated by an isokinetic dynamometer (Biodex 4).

  The dynamometer makes it possible to isolate particular muscle groups. It is possible to control the range of motion and thereby test in an area free of pain.

  The tests takes less than an hour and are only done once.

Secondary Outcomes (1)

• Assessment of the muscle strength by a clinical test using "the Medical Research Council Scale for muscle strength" (MRC-scale).

  The exam lasts 15 min.

Interventions

MRI and muscle dynamometer OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with verified mitochondrial disease.

You may qualify if:

• Verified mitochondrial disease.
• Age: Over 18 years old

You may not qualify if:

• Contraindications for an MRI.
• Claustrophobia.
• Pregnant or nursing women.
• Competing disorders (as arthritis) or other muscle disorders.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen East, 2100, Denmark

Location

Related Publications (2)

• Lightowlers RN, Taylor RW, Turnbull DM. Mutations causing mitochondrial disease: What is new and what challenges remain? Science. 2015 Sep 25;349(6255):1494-9. doi: 10.1126/science.aac7516. Epub 2015 Sep 24.

  PMID: 26404827 BACKGROUND

• Paternostro-Sluga T, Grim-Stieger M, Posch M, Schuhfried O, Vacariu G, Mittermaier C, Bittner C, Fialka-Moser V. Reliability and validity of the Medical Research Council (MRC) scale and a modified scale for testing muscle strength in patients with radial palsy. J Rehabil Med. 2008 Aug;40(8):665-71. doi: 10.2340/16501977-0235.

  PMID: 19020701 BACKGROUND

Related Links

• Home page with knowledge about mitochondrial diseases. Used to write the "Background" in the study protocol.

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nanna S Nielsen, B.Sc

  Copenhagen Neuromuscular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student researcher

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)