NCT02314338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 1, 2016

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

November 27, 2014

Last Update Submit

December 31, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short physical performance battery (SPPB)

    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 Outcomes (9)

  • Lung function

    4 weeks

  • 6-minute walk test (6MWT)

    4 weeks

  • Borg category ratio-10 scale (Borg CR-10 scale)

    4 weeks

  • Peripheral oxygenation level

    4 weeks

  • Bilateral leg press 1 repetition Maximum (RM)

    4 weeks

  • +4 more secondary outcomes

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

Multi-disciplinary pulmonary rehabilitation

Other: Pulmonary rehabilitation

Interventions

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

Pulmonary rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-klinikkene Glittre

Hakadal, 1485, Norway

Location

Related Publications (1)

  • Larsson P, Borge CR, Nygren-Bonnier M, Lerdal A, Edvardsen A. An evaluation of the short physical performance battery following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. BMC Res Notes. 2018 Jun 4;11(1):348. doi: 10.1186/s13104-018-3458-7.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Edvardsen, PhD

    LHL-klinikkene Glittre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 11, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 1, 2016

Record last verified: 2015-09

Locations