COPDNCT01981200
Feasibility of Strength Training in Patients Hospitalized Due to COPD
A study testing Resistance training in AECOPD in people with COPD and Muscle Weakness, run by Frederikssunds Hospital, Denmark at 1 site in Denmark.
Trial summary
To examine the feasibility of progressive unilateral knee-extension strength training using ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Muscle Weakness
- What is being tested?
- Resistance training in AECOPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jan 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a primary diagnosis of COPD
- Be admitted to the pulmonary ward due to an exacerbation in COPD
- Provide informed consent to participation in the study
- Be able to maintain an upright position on a chair
- Be able to be guided to training and understand instructions for participating
Who cannot join
- Patients suffering from diseases that prevents the use of wrist weights such as
- Deep venous thrombosis (DVT)
- Erysipelas
- Painful edema of the limbs
- Lack of ability to walk, habitually
- Predicted hospital stay of less than four days as predicted by a pulmonary physician
- Patients admitted Friday night or Saturday morning cannot be stared up within 24 hours of admittance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Progressive Knee Extension Strength Training Using Ankle Weight Cuffs in Patients Hospitalized With COPD in Acute Exacerbation
To examine the feasibility of progressive unilateral knee-extension strength training using ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD
Read the detailed description
We decided that feasibility is indicated if: 1) the absolute training loads increase progressively, 2) more than 80% of the planned training sessions are completed, and 3)if the absolute training loads do not exceed 20 kg (2 x10kg weight cuffs) for 90% of patients.
- Conditions
- COPD, Muscle Weakness
- Being tested
- Resistance training in AECOPD
- Keywords
- COPD acute exacerbation, Physiotherapy, Resistance training, Muscle strength, Handheld dynamometer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training in AECOPDOther
Also called Weight cuffs, Strength training, hospitalization
The patients begin training on day 1 of admittance. The training consists of knee extension performed in the sitting position on the bed with a 90 degrees of flexion of the knees. The weight cuffs are tired to the angles with a weight corresponding to 10 RM (the weight lifted 10 times). The weights and exercises are subjected to supervision on daily basis by the physiotherapist. The weight is increased after every set of training if more than 10 rep. can be performed with a given weight. Limitations to exercise is also recorded along with the degree of dyspnoea as assessed by the Borg CR10, possible oxygen supplementation and saturation is recorded before and following exercise.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training in AECOPD | Experimental | The patients conduct daily training during admission with weight cuff 3 set of 10 rep. Receives: Other: Resistance training in AECOPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of training load during admission
Change in training loads measured by the number of kilos lifted using ankle weight cuffs in 3 sets of 10 repetition maximum at the first training day to the number of kilos lifted at the last training day
Measured: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes (3)
Maximal isometric knee extension strength
Maximal isometric knee extension strength is measured unilaterally by a fixated handheld dynamometer. The test will be performed upon admission and at the day of discharge
Measured: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Sit-to- stand- test
The number of times the patient comes to full standing position in 30 seconds. The Sit to Stand test provides a measurement of a person's lower body (particularly quadriceps) strength. This is associated with the ability to perform lifestyle tasks such as climbing stairs, getting in and out of a vehicle or bath. The test will be performed upon admission and on the day of discharge
Measured: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Timed Up and Go (TUG)
A test used to assess a person's mobility and requires both static and dynamic balance. The time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit Down. The test will be performed at admission and at the day of discharge
Measured: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederikssunds Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Linette Marie Kofod, Frederikssunds Hospital, Denmark
- Investigators
- Linette M Kofod, PT, Principal investigator, Nordsjællands Hospital - FrederikssundMorten T Kristensen, PhD, Study chair, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981200
- Sponsor's protocol ID
- 210977
- Status last verified
- Feb 2014
- First submitted
- 30 Oct 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Progressive Knee Extension Strength Training Using Ankle Weight Cuffs in Patients Hospitalized With COPD in Acute Exacerbation
- ClinicalTrials.gov ID
- NCT01981200
- Acronym / sponsor ID
- 210977
- Conditions
- COPD, Muscle Weakness
- Keywords
- COPD acute exacerbation, Physiotherapy, Resistance training, Muscle strength, Handheld dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Frederikssunds Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Nov 2013 (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.
To examine the feasibility of progressive unilateral knee-extension strength training using ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD
Detailed description
We decided that feasibility is indicated if: 1) the absolute training loads increase progressively, 2) more than 80% of the planned training sessions are completed, and 3)if the absolute training loads do not exceed 20 kg (2 x10kg weight cuffs) for 90% of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance training in AECOPD | Experimental | Other: Resistance training in AECOPDThe patients conduct daily training during admission with weight cuff 3 set of 10 rep. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have a primary diagnosis of COPD
- Be admitted to the pulmonary ward due to an exacerbation in COPD
- Provide informed consent to participation in the study
- Be able to maintain an upright position on a chair
- Be able to be guided to training and understand instructions for participating
Key exclusion criteria (7 listed)
- Patients suffering from diseases that prevents the use of wrist weights such as
- Deep venous thrombosis (DVT)
- Erysipelas
- Painful edema of the limbs
- Lack of ability to walk, habitually
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance training in AECOPDAlso: Weight cuffs, Strength training, hospitalizationThe patients begin training on day 1 of admittance. The training consists of knee extension performed in the sitting position on the bed with a 90 degrees of flexion of the knees. The weight cuffs are tired to the angles with a weight corresponding to 10 RM (the weight lifted 10 times). The weights and exercises are subjected to supervision on daily basis by the physiotherapist. The weight is increased after every set of training if more than 10 rep. can be performed with a given weight. Limitations to exercise is also recorded along with the degree of dyspnoea as assessed by the Borg CR10, possible oxygen supplementation and saturation is recorded before and following exercise. | Other | Resistance training in AECOPD |
Primary outcome
Increase of training load during admission
Time frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Change in training loads measured by the number of kilos lifted using ankle weight cuffs in 3 sets of 10 repetition maximum at the first training day to the number of kilos lifted at the last training day
3 secondary outcomes
Maximal isometric knee extension strength
Time frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Sit-to- stand- test
Time frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days
Timed Up and Go (TUG)
Time frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days
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 Feb 2014.
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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.
Linette M Kofod, PT principal investigator
Nordsjællands Hospital - Frederikssund
Morten T Kristensen, PhD study chair
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in AECOPD in people with COPD and Muscle Weakness, run by Frederikssunds Hospital, Denmark at 1 site in Denmark.
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 7 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 Feb 2014. 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 Denmark. 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.
What does the primary outcome measure?
Increase of training load during admission (time frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days). It is what the study was designed to measure, not a finding.
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 Feb 2014.