Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Completion Rate
Study Overview
Brief Summary
The purpose of the study is to determine the feasibility and preliminary efficacy of a combined therapeutic yoga and resistance exercise intervention for individuals with lung cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by tailoring the program to meet the specific needs of the survivor with lung cancer. The investigators want to see whether individuals with lung cancer and their caregivers are interested in participating in this type of program, and if they are able to attend the intervention sessions and complete the program. The investigators also plan to study the preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both individuals with lung cancer and their caregivers.
Detailed Description
To determine the feasibility of a combined therapeutic yoga and resistance exercise intervention for lung cancer survivors and their caregivers. A single group before and after intervention study design will be used for this pilot feasibility trial. Brochures and information about the study will be distributed at the Cross Cancer Institute, and interested individuals will be screened for eligibility. A convenient sampling technique will be used to recruit individuals with lung cancer and their caregiver. Participants deemed eligible to take part in the study will provide written informed consent to participate in the study and will undergo baseline testing. The intervention will be carried out over a period of 8 weeks. The feasibility outcomes will include eligibility rate, completion rate, adherence rate and adverse events. Dyspnea will be the primary self-reported outcome to be measured for individuals with lung cancer. The secondary outcomes will include fatigue, shoulder range of motion, chest expansion, and muscular strength. The outcome measures for the caregivers will include quality of life (QoL) and muscular strength.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of Primary Lung Cancer Stage I-IV (all stages)
- •Any form of Lung cancer included: Small Cell Lung Cancer and Non-Small Cell Lung Cancer
- •Age: 18 years or above
- •Patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment
- •Karnofsky Performance Status ≥ 50 (Appendix A)
- •Life expectancy at least one year -
Exclusion Criteria
- •Metastatic lung disease that would preclude safe exercise prescription
- •Secondary Lung cancer due to metastasis from other parts of body
- •Co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases.
- •Individuals who would be unsafe to participate in an intervention program.
- •Unable to provide consent in English
- •Unable to complete either testing or intervention components (e.g. extended holiday)
- •Caregiver eligibility: Caregivers will be screened using the PAR-Q + questionnaire and will be required to obtain approval from a family physician should any safety concerns be identified.
Arms & Interventions
Therapeutic Yoga and Resistance Exercise
The individuals with lung cancer and their caregivers will participate in a combined intervention of yoga and resistance exercise for 8-week, two times/week. The dyad will attend a one-hour resistance exercise intervention at the start of the week and a one-hour yoga class with a break of one day between both interventions. The resistance exercise training will involve one-on-one personal exercise session, while the yoga intervention will be offered in a class setting. The participants will be allowed to make up for any missed resistance exercise session based on the available time. Pamphlets will be given demonstrating breathing exercises, meditation, postures, and core resistance exercises to facilitate programming.
Intervention: Therapeutic Yoga and Resistance Exercise (Behavioral)
Outcomes
Primary Outcomes
Completion Rate
Time Frame: Up to 24 weeks
Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.
Secondary Outcomes
- Chest expansion (centimetres)(8 weeks)
- Muscular strength(8 weeks)
- Adverse Event(up to 24 weeks)
- Chalder Fatigue Scale (Caregivers only)(8 weeks)
- Dyspnoea Visual Analogue Scale(8 weeks)
- Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)(8 weeks)
- Adherence Rate(up to 8 weeks)
- Recruitment rate(24 weeks)
- Dyspnoea-12(8 weeks)
- Shoulder Range of Motion (degrees)(8 weeks)
- CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)(8 weeks)
- Pulmonary Function Testing(8 weeks)