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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Frederikssund, Denmark, 3600
        • Nordsjællands Hospital - Frederikssund

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance training in AECOPD
The patients conduct daily training during admission with weight cuff 3 set of 10 rep.
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.
Other Names:
  • Strength training
  • Weight cuffs
  • hospitalization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frederikssunds Hospital, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Copenhagen University Hospital, Hvidovre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 210977

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