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HEALTH-2007-2.4.5-10: Understanding and combating age related muscle weakness *MYOAGE*

HEALTH-2007-2.4.5-10: Understanding and combating age related muscle weakness *MYOAGE* - MYOAGE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34394
Enrollment
265
Registered
2010-05-31
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Age related muscle weakness Sarcopenia

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: PHASE 1: Inclusion: •patients undergoing either total knee replacement or knee periarticular reconstruction (fracture repair, corrective osteotomy, capsular ligament reconstruction) that provide for an open surgery in the lateral part of distal femur; or total/partial hip replacement or proximal femur osteosynthesis. PHASE 2: Inclusion: • healthy young: age ranges 18-30 years; • elderly: age 70-80 years, free living, ADL independent

Exclusion criteria

Exclusion criteria: PHASE 1:;Exclusion: • patients less than 20 years • patients that underwent previous open surgery in parts concerned the biopsy collection • patients with rheumatoid diseases (RA, polymyositis, dermatomyositis etc) • patients that undergo insulin therapy • patients with haemocoagulative syndromes in which collection could cause strong bleeding • patients with serious neuromuscular disease (flabby and spastic paralysis of legs, myasthenia, myodystrophia • patients with serious hepatorenal failure • patients with serious infectious disease and active malignant neoplasia • patients with serious psychiatric disorders, chronic abuse of alcohol and drugs • patients that use steroidal medicines • patients unable to give a personal consent • Participating in other ongoing research projects.;PHASE 2: Exclusion: • Participating in other ongoing research projects. • patients unable to give a personal consent • walking distance 250m and less; • MMSE 23 and lower; • GDS 5 and higher; • institutionalized; • comorbidity: neurological disorders (stroke, M. Parkinson, dementia, muscle disease), metabolic diseases (insuline dependent DM), arthritis: rheumatoid arthritis, severe (pain and functional limitation) osteoarthritis (hip and knee), cancer: diagnosis and treatment of cancer within the last year, polymyalgia rheumatic, heart failure (NYHA 3-4), COPD (Gold 3-4), chronic pain syndrome (fibromyalgia, complex regional pain syndrome etc); haemocoagulative syndromes in which biopsy could cause strong bleeding. • medication: immunosuppressive drugs (e.g. prednisone, methotrexat, biologicals (TNF-alpha antagonists etc)), insulin, anticoagulantia, e.g. coumarines, carbaspirin calcium. • fracture last year; • hip and knee replacement in medical history last 2 years; • hip and knee replacement causing pain and physical limitation; • amputation; • immobilization for 1 week during the last 3 months; • sports on a highly competitive level • severe hearing impairment. • severe visual impairment ..

Design outcomes

Primary

MeasureTime frame
PHASE I Muscle biopsies: Myoblastic proliferative capacity; muscle histology: number of satellite cells, proportion of the different types of fibres and the volume of fibres as well as the number of nuclei/fibres, proportion between fibres to adipocytes;, protein/RNA/DNA characteristics Percutaneous muscle biopsy will be used to compare with muscle material taken by open surgery (if comparable). Blood: Haematological measurements (Hb, MCV, Leukocytes, Thrombocytes), cytokine assays, PBMCs, LPS/Pam3Cys whole blood stimulation assays, CRP, albumine, kreatinine, GH, IGF-1 and BMP-4, pro as well as anti inflammatory cytokines (IL-12, IFNγ, IL-6, TNFa) Number of B cells, T cell subsets, monocytes and natural killer cells. Naïve, memory and regulatory T cell subsets. Skin and fat biopsies: proliferative capacity (comparison with myoblasts); skin histology: number of senescent cells (comparison with myoblast culture and muscle histology), inflammatory phenotype (comparison with blood stimulation and stimulation of myoblasts), protein/RNA/DNA characteristics (comparison with muscle tissue). Anthropometric measures Length, arm span, weight and waist circumference. PHASE II Blood: haematological measurements (Hb, MCV, Leukocytes, Thrombocytes), cytokine assays, PBMCs, LPS/Pam3Cys whole blood stimulation assays, CRP, albumine, kreatinine, Calcium, Vitamin D, GH, IGF-1 and BMP-4, pro as well as anti inflammatory cytokines (IL-12, IFNγ, IL-6, TNFa) Number of B cells, T cell subsets, monocytes and natural killer cells. Naïve, memory and regulatory T cell subsets; glucose tolerance (mmol/L), Questionnaires: QoL; present and past education, employment and levels of physical activity, medical history and current medication. ADL dependency DEXA: Muscle mass/ fat content of the upper and lower limbs; bone mineral density Lungfunction: FEV1 (L/s), FEV (L), FEV1/FEV ratio (%), Total lung capacity (L), Tidal Volume (L) Grip strength (Kg) Gross

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)