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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01981200
Other study ID # 210977
Secondary ID
Status Completed
Phase N/A
First received October 30, 2013
Last updated February 9, 2014
Start date October 2013
Est. completion date January 2014

Study information

Verified date February 2014
Source Frederikssunds Hospital, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Resistance training in AECOPD
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.

Locations

Country Name City State
Denmark Nordsjællands Hospital - Frederikssund Frederikssund

Sponsors (2)

Lead Sponsor Collaborator
Frederikssunds Hospital, Denmark Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The patients will be followed for the duration of hospital stay, an expected average of 6 days No
Secondary 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 The patients will be followed for the duration of hospital stay, an expected average of 6 days No
Secondary 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 The patients will be followed for the duration of hospital stay, an expected average of 6 days No
Secondary 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 The patients will be followed for the duration of hospital stay, an expected average of 6 days No
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