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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179178
• Other study ID #: UGOTTriad
• Secondary ID: Grant
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: August 10, 2010
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2006
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 81 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Malnutrition
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Sweden	Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg	Göteborg

Sponsors (4)

Lead Sponsor	Collaborator
Göteborg University	Swedish Heart Lung Foundation, The Swedish Heart and Lung Association, The Swedish Research Council

Country where clinical trial is conducted

Sweden,