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Studie zur Wirksamkeit von hyperkalorischer Ernährung und Androgengabe auf die körperliche Leistungsfähigkeit und Lebensqualität von Patienten mit schwerer COPD

Studie zur Wirksamkeit von hyperkalorischer Ernährung und Androgengabe auf die körperliche Leistungsfähigkeit und Lebensqualität von Patienten mit schwerer COPD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004291-20-AT
Enrollment
120
Registered
2006-04-05
Start date
2006-06-08
Completion date
Unknown
Last updated
2016-11-21

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

Conditions

Evaluation of the effects of testosteronundecanoat and hypercaloric nutrition in addition to rehabilitative training for patients with severe and very severe COPD

Interventions

Trade Name: Nebido 1000 mg/4ml Ampullen Pharmaceutical Form: Injection*

Sponsors

Prof.Dr.Hartmut ZWICK
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male participants COPD (GOLD III and IV) Age 45 - 80 yrs BMI =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prostatic hyperplasia Prostatic carcinoma Pathological values of PSA, blood-sugar and blood-count Hypercaloric nutrition within 6 months before study Androgenic therapy or anabolic steroids within 6 months before study Unstable condition of an other sickness Unstable COPD Chronic pain Immobility Pathologic. psychiatric and psychologic condition Alcohol and drug abusus

Design outcomes

Primary

MeasureTime frame
Main Objective: Enhancement of quality of life and capacity of patients with COPD (GOLD III and IV) and BMI <20. Evaluation of influence of dispension of serumtestosteron and hypercaloric nutrition on muscular strength and aerobic capacity;Secondary Objective: ;Primary end point(s): Change of the strength of the musculus quadriceps femoris Change of maximal inspiratory pressure Change of maximal aerobic capacity Change of health related quality of life Change of fat free body mass

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026