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Completed

NCT Number: NCT01179178

A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition

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.

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Key information

Age range

65 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg

Gothenburg, 44232, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Swedish Heart Lung Foundation
  • The Swedish Heart and Lung Association
  • The Swedish Research Council

Registry information

Official study title

A Dangerous Triad in Ageing and in COPD - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2010
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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