An Evaluation of Web Based Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

— webbasedPR  

Official title:

An Evaluation of Web Based Pulmonary Rehabilitation- Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404831
• Other study ID #: L13099
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2014
• Last updated: July 23, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic Obstructive Pulmonary Disease (COPD) is a term used to describe a number of lung conditions characterised by irreversible damage to the airways causing airflow obstruction. Pulmonary Rehabilitation (PR) is a broad programme that helps improve the health and well-being of people with breathing difficulties, most commonly COPD. Participation in PR leads to improvements in exercise tolerance and functional ability, as well as a reducing breathlessness in everyday activities. It is traditionally an outpatient programme based in a hospital or community setting run by a multidisciplinary team, and usually lead by physiotherapy and nursing staff. Typically it includes a physical exercise programme, and advice and education on managing a chronic lung condition. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of COPD

• Suitable for participation in the NHS Lanarkshire PR programme

• Independently mobile

• Access to the internet in their own home

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Web-based PR
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.
• Hospital-based PR
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.

Locations

Country	Name	City	State
United Kingdom	Monklands Hospital	Airdrie

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Research and Development

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Hospital Anxiety and Depression Scale at 6 weeks		6 weeks	No
Other	Change from baseline in Borg Breathlessness Scale at 6 weeks		6 weeks	No
Other	Website evaluation questionnaire	questionnaire completed by Experimental Group only	6 weeks	No
Other	Semi-structured telephone interviews	Qualitative interview conducted with Experimental Group only	6 weeks	No
Primary	Change from baseline in Shuttle Walk test at 6 weeks	analysis	6 weeks	Yes
Secondary	Change from baseline in Chronic Disease Questionnaire at 6 weeks	questionnaire	6 weeks	No