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Completed

NCT Number: NCT02314338

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHL-klinikkene Glittre

Hakadal, 1485, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pulmonary Rehabilitation

Other

In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lung function

    Time frame: 4 weeks

    spirometry and/or whole body plethysmography

  2. 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.

  3. 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. Peripheral oxygenation level

    Time frame: 4 weeks

    Peripheral oxygenation level (SpO2) will be measured indirectly by pulse oximetry during the 6 MWT.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

LHL Helse

Other

Collaborators

  • Karolinska Institutet
  • Lovisenberg Diakonale Hospital

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2014
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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