- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981200
Feasibility of Strength Training in Patients Hospitalized Due to COPD
February 9, 2014 updated by: Linette Marie Kofod, Frederikssunds Hospital, Denmark
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Frederikssund, Denmark, 3600
- Nordsjællands Hospital - Frederikssund
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance training in AECOPD
The patients conduct daily training during admission with weight cuff 3 set of 10 rep.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The patients will be followed for the duration of hospital stay, an expected average of 6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal isometric knee extension strength
Time Frame: The patients will be followed for the duration of hospital stay, an expected average of 6 days
|
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
|
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
|
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
|
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
|
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
|
The patients will be followed for the duration of hospital stay, an expected average of 6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Morten T Kristensen, PhD, Copenhagen University Hospital, Hvidovre
- Principal Investigator: Linette M Kofod, PT, Nordsjællands Hospital - Frederikssund
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (Estimate)
November 11, 2013
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 9, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210977
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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