NCT02404831

Brief Summary

The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2014

Typical duration for phase_1 chronic-obstructive-pulmonary-disease

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

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

December 2, 2014

Last Update Submit

July 23, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

PhysiotherapyPulmonary RehabilitationExerciseTelerehab

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Shuttle Walk test at 6 weeks

    analysis

    6 weeks

Secondary Outcomes (1)

  • Change from baseline in Chronic Disease Questionnaire at 6 weeks

    6 weeks

Other Outcomes (4)

  • Change from baseline in Hospital Anxiety and Depression Scale at 6 weeks

    6 weeks

  • Change from baseline in Borg Breathlessness Scale at 6 weeks

    6 weeks

  • Website evaluation questionnaire

    6 weeks

  • +1 more other outcomes

Study Arms (2)

Traditional hospital-based PR

ACTIVE COMPARATOR

Class based pulmonary rehabilitation

Other: Hospital-based PR

Web-based PR

EXPERIMENTAL

web-based pulmonary rehab

Other: Web-based PR

Interventions

Web-based PROTHER

Participants will undertake web-based PR twice/week for 6 weeks in their own home. They will be given individual log-in details to access the website with access to exercises and education pages. Participants will be provided with a standardised exercise programme at the start of the study. The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group. Participant log-ins and diaries will be monitored remotely and participants will be telephone at weeks 2 and 4 by their physiotherapist to discuss their progress and, at this time, exercises may be progressed by changing the level of difficulty/intensity. This is done remotely by physiotherapy staff.

Web-based PR
Hospital-based PROTHER

Participants allocated to this group will undertake hospital-based PR twice per week for 6 weeks in. Participants attend PR classes and complete a circuit based exercise class. The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group. Following each class they will receive educational information about their condition.

Traditional hospital-based PR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of COPD
  • Suitable for participation in the NHS Lanarkshire PR programme
  • Independently mobile
  • Access to the internet in their own home

You may not qualify if:

  • Unstable cardiac or other health problems which may prevent participation in study
  • Under the age of 18
  • Pregnant
  • Unable to read/understand English
  • Unwilling to be randomised into PR delivered via the hospital or internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monklands Hospital

Airdrie, ML60JS, United Kingdom

Location

Related Publications (1)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PMID: 33511633DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lorna Paul, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 2, 2014

First Posted

April 1, 2015

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

GB(1)