Therapeutic Yoga and Resistance Exercise for Lung Cancer

Lung Cancer Clinical Trial

— ASSURE  

Official title:

Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084692
• Other study ID #: HREBA.CC-17-0049
• Status: Completed
• Phase: N/A
• Start date: April 14, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: April 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 31, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of Primary Lung Cancer Stage I-IV (all stages)

2. Any form of Lung cancer included: Small Cell Lung Cancer and Non-Small Cell Lung Cancer

3. Age: 18 years or above

4. Patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment

5. Karnofsky Performance Status = 50 (Appendix A)

6. Life expectancy at least one year -

Exclusion Criteria:

1. Metastatic lung disease that would preclude safe exercise prescription

2. Secondary Lung cancer due to metastasis from other parts of body

3. Co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases.

4. Individuals who would be unsafe to participate in an intervention program.

5. Unable to provide consent in English

6. 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Therapeutic Yoga and Resistance Exercise
Combined Program of Yoga and Resistance Exercise

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate	Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.	Up to 24 weeks
Secondary	Dyspnoea Visual Analogue Scale	Visual Analogue Scale used to measure subjective breathlessness of a horizontal 10-cm line with phrases at both ends of the scale demonstrating minimum and maximum level of breathlessness.	8 weeks
Secondary	Dyspnoea-12	The dyspnea-12 consists of 12 item scale to which patients respond about their general perception of their current state. It quantifies breathlessness using descriptions by patients of both physical and affective aspects of dyspnoea.	8 weeks
Secondary	Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)	The FACT-F was developed to measure fatigue in oncology patients with anemia. It has 13 items, which cover physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue.	8 weeks
Secondary	Chest expansion (centimetres)	The circumference of the chest is measured after an inspiration and an expiration using a tape at the level xiphisternum in standing position, using two different arm positions: hands on head and arms at the side.	8 weeks
Secondary	Shoulder Range of Motion (degrees)	Active Flexion and Abduction will be measured using a handheld goniometer with the participant in a sitting position.	8 weeks
Secondary	Muscular strength	All participants, the individuals with lung cancer and their caregivers will perform a 1RM test before and after the 8-week intervention, to measure the changes in their muscle strength of upper extremity and lower extremity on a bench press, seated row, and a leg press.	8 weeks
Secondary	Pulmonary Function Testing	The lung volumes and capacities will be measured using the spirometer in a sitting position. The forced expiratory volume in one second (fev1) and the forced vital capacity (fvc) will be measured.	8 weeks
Secondary	CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)	The CareGiver Oncology Quality of Life (CarGOQoL) questionnaire is a 29-item, multidimensional, self-administered questionnaire.	8 weeks
Secondary	Chalder Fatigue Scale (Caregivers only)	Chalder Fatigue Scale is an 11 item scale to assess symptoms of fatigue such as tiredness, sleepiness, lack of energy, lack of strength in the muscles, difficulties in concentration and memory.	8 weeks
Secondary	Adherence Rate	Attendance at exercise sessions	up to 8 weeks
Secondary	Recruitment rate	The number of participants agreeing to participate divided by the total number eligible	24 weeks
Secondary	Adverse Event	Incidence of serious and non-serious adverse events will be recorded	up to 24 weeks