The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)

December 31, 2015 updated by: LHL Helse

The Short Physical Performance Battery in COPD - Possible Impact of a Pulmonary Rehabilitation Program and Relationships to Other Physical Performance Measures, Symptoms, and Quality of Life.

Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. SPPB has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. The investigators would like to evaluate possible changes in the SPPB score after a 4-week rehabilitation program. The investigators would also like to look at possible relationships between the SPPB and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • Norway
      • Hakadal, Norway, 1485
        • LHL-klinikkene Glittre

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:

  • Patients with all stages of COPD
  • Decision making capacity to provide informed written consent
  • Ability to understand and complete the questionnaires

Exclusion Criteria:

  • Exacerbation within the last four weeks
  • Co-morbidities that limits the patient's physical performance more than COPD
  • Any patient whom is deemed unsafe to exercise
  • Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary rehabilitation
Multi-disciplinary pulmonary rehabilitation
Other: Pulmonary rehabilitation
In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short physical performance battery (SPPB)
Time Frame: Pre and posttest with 4 weeks in between
SPPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.
Pre and posttest with 4 weeks in between

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: 4 weeks
spirometry and/or whole body plethysmography
4 weeks
6-minute walk test (6MWT)
Time Frame: 4 weeks
The 6 MWT is a timed walk test. Participants are asked to walk as far as possible, in 6 minutes. Borg CR-10 score and SpO2 will be measured before, during and/or after the 6 MWT.
4 weeks
Borg category ratio-10 scale (Borg CR-10 scale)
Time Frame: 4 weeks
The Borg CR-10 scale is a rating scale for self-reported symptoms, in this case dyspnea. 0 represents no symptoms and 10 the worst previously experienced symptoms.
4 weeks
Peripheral oxygenation level
Time Frame: 4 weeks
Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.
4 weeks
Bilateral leg press 1 repetition Maximum (RM)
Time Frame: 4 weeks
1 RM bilateral leg press will be administered, after a brief warm-up, as a measure of leg strength. Starting position: Legs shoulder width apart and knee at 90 degrees angle.
4 weeks
Modified Medical Research Council Dyspnea Scale (MMRC)
Time Frame: 4 weeks
A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with COPD. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 is a person who are to breathless to leave the house, or breathless when dressing/undressing.
4 weeks
COPD assessment test (CAT)
Time Frame: 4 weeks
CAT is a disease-specific quality of life questionnaire. It has 8-items and a total range of 0-40, where 40 represents more severe impact of COPD on a patient's life.
4 weeks
Hospital anxiety and depression scale (HADS)
Time Frame: 4 weeks
14-item questionnaire for screening for anxiety and depression. Each item is scored from 0-3 and each person can have a score between 0-21 for either anxiety or depression.
4 weeks
Fatigue severity scale (FSS)
Time Frame: 4 weeks
9- item scale that measures the impact of fatigue on a person's activities and lifestyle. Range 9-63. Higher score- greater fatigue severity.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LHL Helse

Collaborators

Karolinska Institutet
Lovisenberg Diakonale Hospital

Investigators

  • Principal Investigator: Anne Edvardsen, PhD, LHL-klinikkene Glittre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK2014/1499

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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