- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03084692
Therapeutic Yoga and Resistance Exercise for Lung Cancer (ASSURE)
October 12, 2018 updated by: University of Alberta
Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2G4
- University of Alberta/ Cross Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Combined Program of Yoga and Resistance Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnoea Visual Analogue Scale
Time Frame: 8 weeks
|
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
|
Dyspnoea-12
Time Frame: 8 weeks
|
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
|
Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)
Time Frame: 8 weeks
|
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
|
Chest expansion (centimetres)
Time Frame: 8 weeks
|
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
|
Shoulder Range of Motion (degrees)
Time Frame: 8 weeks
|
Active Flexion and Abduction will be measured using a handheld goniometer with the participant in a sitting position.
|
8 weeks
|
Muscular strength
Time Frame: 8 weeks
|
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
|
Pulmonary Function Testing
Time Frame: 8 weeks
|
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
|
CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)
Time Frame: 8 weeks
|
The CareGiver Oncology Quality of Life (CarGOQoL) questionnaire is a 29-item, multidimensional, self-administered questionnaire.
|
8 weeks
|
Chalder Fatigue Scale (Caregivers only)
Time Frame: 8 weeks
|
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.
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8 weeks
|
Adherence Rate
Time Frame: up to 8 weeks
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Attendance at exercise sessions
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up to 8 weeks
|
Recruitment rate
Time Frame: 24 weeks
|
The number of participants agreeing to participate divided by the total number eligible
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24 weeks
|
Adverse Event
Time Frame: up to 24 weeks
|
Incidence of serious and non-serious adverse events will be recorded
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 14, 2017
Primary Completion (ACTUAL)
May 30, 2018
Study Completion (ACTUAL)
May 31, 2018
Study Registration Dates
First Submitted
March 14, 2017
First Submitted That Met QC Criteria
March 20, 2017
First Posted (ACTUAL)
March 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREBA.CC-17-0049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Undecided at this time.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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