NCT01179178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
Last Updated

August 11, 2010

Status Verified

January 1, 2006

Enrollment Period

3.8 years

First QC Date

August 9, 2010

Last Update Submit

August 10, 2010

Conditions

Study Arms (2)

COPD-patients

Older adults (65-81 y)

Eligibility Criteria

Age65 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients (COPD) and older adults living in Gothenburg

You may qualify if:

  • 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

You may not qualify if:

  • Any specific muscular disease
  • Severe disease or handicap making investigations impossible
  • Any specific muscular disease
  • Any co-existing serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg

Gothenburg, 44232, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 11, 2010

Study Start

March 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 11, 2010

Record last verified: 2006-01

Locations