Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Rehabilitation for Elderly Patients With COPD and Their Families: Promoting a Comprehensive, Integrated Intervention Based on the International Classification of Functioning, Disability and Health (ICF)
The purpose of this study is to explore the impact of Family-based pulmonary rehabilitation
(PR) on patients with chronic obstructive pulmonary disease (COPD) and their family members.
Dyads (patient and respective family member) will be randomly allocated to either a
Family-based PR group or a Conventional PR group. PR programs will consist of exercise
training and psychoeducation. In the Family-based PR program, both patients and family
members will participate in psychoeducation sessions. In the Conventional PR group, only
patients will be included. In both groups, exercise training sessions will be exclusively
for patients.
It is expected that, by including patients with COPD and their family members in
Family-based PR, they will become more competent and confident in the management of the
disease, thus reducing the overall impact of COPD on patients and family members'
well-being.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria for patients: - clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria - = 18 years old - clinically stable - able to provide their own informed consent Exclusion criteria for patients: - presence of severe psychiatric conditions - inability to understand and co-operate - exacerbations or hospital admissions one month prior to the intervention - presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease Inclusion criteria for family members: - caring for a relative with COPD on a regular basis - = 18 years old - able to provide their own informed consent Exclusion criteria for family members: - presence of severe psychiatric conditions - inability to understand and co-operate |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Portugal | University of Aveiro | Aveiro |
Lead Sponsor | Collaborator |
---|---|
Aveiro University | Fundação para a Ciência e a Tecnologia |
Portugal,
Figueiredo D, Gabriel R, Jácome C, Cruz J, Marques A. Caring for relatives with chronic obstructive pulmonary disease: how does the disease severity impact on family carers? Aging Ment Health. 2014;18(3):385-93. doi: 10.1080/13607863.2013.837146. Epub 2013 Sep 20. — View Citation
Figueiredo D, Gabriel R, Jácome C, Marques A. Caring for people with early and advanced chronic obstructive pulmonary disease: how do family carers cope? J Clin Nurs. 2014 Jan;23(1-2):211-20. doi: 10.1111/jocn.12363. Epub 2013 Aug 2. — View Citation
Jácome C, Marques A, Gabriel R, Figueiredo D. Chronic obstructive pulmonary disease and functioning: implications for rehabilitation based on the ICF framework. Disabil Rehabil. 2013 Aug;35(18):1534-45. doi: 10.3109/09638288.2012.745625. Epub 2013 Jan 7. — View Citation
Marques A, Jácome C, Gabriel R, Figueiredo D. Comprehensive ICF core set for obstructive pulmonary diseases: validation of the activities and participation component through the patient's perspective. Disabil Rehabil. 2013 Sep;35(20):1686-91. doi: 10.3109/09638288.2012.750691. Epub 2013 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in activities limitation resulting from breathlessness | The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation. | Before, immediately after, 3 and 6 months after the intervention | No |
Other | Change in Body Mass Index | Before, immediately after, 3 and 6 months after the intervention | No | |
Other | Change in exercise tolerance | Patients' exercise tolerance will be assessed with the 6-minute walk test. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected. | Before, immediately after, 3 and 6 months after the intervention | No |
Other | Change in muscle strength (arm flexors and knee extensors) | Isotonic muscle strength will be assessed with the 10 repetition maximum (10-RM), which is the maximum amount of weight that can be moved through the full range of motion 10 times with the proper technique and without compensatory movements. Isometric muscle strength of the knee extensors will be assessed with a hand-held dynamometer. | Before, immediately after, 3 and 6 months after the intervention | No |
Other | Change in functional balance | Functional balance will be measured with the Timed Up-and-Go test. The time needed to perform the test will be recorded. | Before, immediately after, 3 and 6 months after the intervention | No |
Other | Change in health-related quality of life | The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Scores range from 0 to 100 and higher values indicate a poorer quality of life. | Before, immediately after, 3 and 6 months after the intervention | No |
Primary | Change in family coping behaviors | Family Crisis Oriented Personal Scales (F-COPES) include 5 sub-scales which identify family coping patterns. Higher scores indicate more positive coping and problem solving strategies. | Before, immediately after, 3 and 6 months after the intervention | No |
Secondary | Change in psychosocial adjustment to the disease | Psychosocial adjustment to the disease will be measured using the Psychosocial Adjustment to Illness Scale-Self report (PAIS-SR), which is a 46-item scale with 7 domains. Two types of scores arise from the data: a score from each domain and a total PAIS-SR score, with higher scores indicating poorer adjustment. | Before, immediately after, 3 and 6 months after the intervention | No |
Secondary | Change in psychological well-being (depression, anxiety and stress) | Depression Anxiety Stress Scales are designed to measure the 3 related negative emotional states of depression, anxiety and stress. Higher scores indicate a worst psychological outcome. | Before, immediately after, 3 and 6 months after the intervention | No |
Secondary | Change in caregiving difficulties (for family members only) | Caregiving difficulties will be measured with the Carers Assessment of Difficulties Index (CADI), which comprises 7 sub-scales. Higher scores indicate greater subjective burden. | Before, immediately after, 3 and 6 months after the intervention | No |
Secondary | Patients and family members' perspectives of the Family-based PR program (for Family-based PR group only) | Semi-structured focus group interviews will be conducted with patients and family members to explore the impact of the Family-based PR program. | Immediately after the intervention | No |
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