Pulmonary Disease, Chronic ObstructiveNCT01179178
A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition
An observational study of Pulmonary Disease, Chronic Obstructive, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 65 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Mar 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 81 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Outpatients (COPD) and older adults living in Gothenburg
Who may be able to join
- 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
Who cannot join
- Any specific muscular disease
- Severe disease or handicap making investigations impossible
- Any specific muscular disease
- Any co-existing serious disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Clinical Nutrition, Sahlgrenska Academy at University of Gothenburg
Gothenburg, 44232
About this study
Official title: A Dangerous Triad in Ageing and in 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD-patients | Not described | |
| Older adults (65-81 y) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179178
- Sponsor's protocol ID
- UGOTTriad
- Other IDs
- Grant
- Status last verified
- Jan 2006
- First submitted
- 9 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dangerous Triad in Ageing and in COPD - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition
- ClinicalTrials.gov ID
- NCT01179178
- Acronym / sponsor ID
- UGOTTriad
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD-patients | – | – |
| Older adults (65-81 y) | – | – |
Who may qualify
- Ages
- 65 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Outpatients (COPD) and older adults living in Gothenburg
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Any specific muscular disease
- Severe disease or handicap making investigations impossible
- Any specific muscular disease
- Any co-existing serious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.