Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

NCT01235481 | Completed Phase 3

• 1 other identifier: CDHA-RS/2011-159
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The Public Health Agency of Canada estimates that over 3.5 million Canadians live with chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of chronic lung disease among Canadian provinces, likely a reflection of both the age of the population and high rates of exposures to occupational dusts and smoking. Pulmonary rehabilitation is a multidisciplinary intervention, involving exercise and education for patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to improve patient symptoms, exercise capacity, and quality of life while reducing health resource utilization. Many studies have shown that the benefits of pulmonary rehabilitation tend to diminish over time after program completion. The best interventions to maintain the benefits of pulmonary rehabilitation remain unclear. The purpose of this study is to validate incorporation of an exercise DVD into a maintenance program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion of pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome measures will include exercise capacity, exercise compliance, health-related quality of life, confidence with performing exercise, and satisfaction with the exercise DVD. The primary outcome measure will be a change in functional exercise capacity as determined by the distance walked in 6-minutes, a commonly used and validated assessment tool for patients with chronic lung disease.

Conditions

Lung Diseases

Keywords

pulmonary rehabilitation; exercise therapy; chronic lung disease; self-efficacy

Outcome Measures

Primary Outcomes (1)

• 6MWD

  6 months

Secondary Outcomes (4)

• disease-specific quality of life (CRQ)

  6 months

• exercise compliance

  6 months

• exercise self-efficacy

  6 months

• subject satisfaction

  6 months

Study Arms (2)

Exercise DVD

EXPERIMENTAL

Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training

Device: Exercise DVD; Behavioral: Usual Care

Usual Care

OTHER

Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD

Behavioral: Usual Care

Interventions

Exercise DVD DEVICE

Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation

Also known as: Home exercise training

Exercise DVD

Usual Care BEHAVIORAL

Usual care during maintenance phase post pulmonary rehabilitation

Also known as: No exercise DVD provided

Exercise DVD; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any participant enrolled in pulmonary rehabilitation program

You may not qualify if:

• Patients who do not have access to a DVD player.
• Inability to commit to the study plan.
• Cognitive or language barriers interfering with completion of the study procedures

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Capital Health, Canada: collaborator

Study Sites (2)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Cobequid Community Health Centre

Lower Sackville, Nova Scotia, B4C 0A2, Canada

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Paul Hernandez, MDCM, FRCPC

  Queen Elizabeth II Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

CA (2)