Clinical trial NCT01179178: A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition
Official title: A Dangerous Triad in Ageing and in COPD - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: The Swedish Heart and Lung Association
name: Swedish Heart Lung Foundation
First posted: 2010-08-11
Sex: ALL
Minimum age (years): 65
Maximum age (years): 81
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients (COPD) and older adults living in Gothenburg

Brief summary: The investigators have taken part in the development of simple muscle function tests and studied physical training and energy turnover in patients with chronic obstructive pulmonary disease, COPD. The investigators have found that muscle wasting in COPD is related to poor prognosis and that physical training might lead to improved, less energy-demanding muscle function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor autonomy and, secondarily, fractures. In the planned study the investigators will validate simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle strength, 30 m walking test and balance tests) in both groups by relating them to an involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition (impedance, DXA) and recordings of physical activity. The relation between food intake, systemic inflammation, muscle mass and function will be analysed.

The study has been ethically approved and started in COPD patients and will be expanded to a representative sample of elderly.

Simple, evaluated muscle function tests applied in primary care may be used for early detection of muscle dysfunction in COPD patients and elderly so that early intervention against impaired muscle function can be started. Analyses of food intake and of inflammatory markers might identify factors of special importance for muscle dysfunction, which eventually might lead to improved dietary therapy and pharmacological interventions.


Eligibility criteria: Inclusion Criteria:

* Women and men between 65 and 81 years of age, randomly selected from the national registration, are invited to take part in the study.
* Patients referred to the outpatient clinic of the lung unit at Sahlgrenska University Hospital with a diagnosis of COPD are asked for participation.
* Inclusion criteria for COPD patients:
* Clinical diagnosis of COPD
* FEV% \< normal value minus 2 SD
* Smoking history; 10 pack years or more

Exclusion Criteria:

* Any specific muscular disease
* Severe disease or handicap making investigations impossible
* Exclusion criteria for COPD patients:
* Any specific muscular disease
* Any co-existing serious disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg
Study officials:
References: