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Feasibility of Strength Training in Patients Hospitalized Due to COPD

Primary Purpose

COPD, Muscle Weakness

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Resistance training in AECOPD

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD acute exacerbation, Physiotherapy, Resistance training, Muscle strength, Handheld dynamometer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nordsjællands Hospital - Frederikssund

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistance training in AECOPD

Arm Description

The patients conduct daily training during admission with weight cuff 3 set of 10 rep.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT01981200

First Posted

October 30, 2013

Last Updated

February 9, 2014

Sponsor

Frederikssunds Hospital, Denmark

Collaborators

Copenhagen University Hospital, Hvidovre

1. Study Identification

Unique Protocol Identification Number

NCT01981200

Brief Title

Feasibility of Strength Training in Patients Hospitalized Due to COPD

Official Title

Feasibility of Progressive Knee Extension Strength Training Using Ankle Weight Cuffs in Patients Hospitalized With COPD in Acute Exacerbation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Frederikssunds Hospital, Denmark

Collaborators

Copenhagen University Hospital, Hvidovre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Muscle Weakness

Keywords

COPD acute exacerbation, Physiotherapy, Resistance training, Muscle strength, Handheld dynamometer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resistance training in AECOPD

Arm Type

Experimental

Arm Description

The patients conduct daily training during admission with weight cuff 3 set of 10 rep.

Intervention Type

Other

Intervention Name(s)

Resistance training in AECOPD

Other Intervention Name(s)

Weight cuffs, Strength training, hospitalization

Intervention Description

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.

Primary Outcome Measure Information:

Title

Increase of training load during admission

Description

Time Frame

The patients will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcome Measure Information:

Title

Maximal isometric knee extension strength

Description

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

Time Frame

The patients will be followed for the duration of hospital stay, an expected average of 6 days

Title

Sit-to- stand- test

Description

Time Frame

The patients will be followed for the duration of hospital stay, an expected average of 6 days

Title

Timed Up and Go (TUG)

Description

Time Frame

The patients will be followed for the duration of hospital stay, an expected average of 6 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linette M Kofod, PT

Organizational Affiliation

Nordsjællands Hospital - Frederikssund

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Morten T Kristensen, PhD

Organizational Affiliation

Copenhagen University Hospital, Hvidovre

Official's Role

Study Chair

Facility Information:

Facility Name

Nordsjællands Hospital - Frederikssund

City

Frederikssund

ZIP/Postal Code

3600

Country

Denmark

12. IPD Sharing Statement

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Feasibility of Strength Training in Patients Hospitalized Due to COPD

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