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

NCT ID: NCT01179178

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD-patients

No interventions assigned to this group

Older adults (65-81 y)

No interventions assigned to this group

Eligibility Criteria

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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.
* 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
* Any specific muscular disease
* Any co-existing serious disease
Minimum Eligible Age

65 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

The Swedish Heart and Lung Association

OTHER

Sponsor Role collaborator

Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Locations

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Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UGOTTriad

Identifier Type: -

Identifier Source: org_study_id

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