Lung CancerASSURENCT03084692
Therapeutic Yoga and Resistance Exercise for Lung Cancer
A study testing Therapeutic Yoga and Resistance Exercise in people with Lung Cancer, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Therapeutic Yoga and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Therapeutic Yoga and Resistance Exercise
- Keywords
- caregiver, lung cancer, yoga, resistance exercise
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Yoga and Resistance ExerciseBehavioural
Combined Program of Yoga and Resistance Exercise
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Yoga and Resistance Exercise | Experimental | 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. Receives: Behavioral: Therapeutic Yoga and Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.
Measured: Up to 24 weeks
Secondary outcomes (12)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Shoulder Range of Motion (degrees)
Active Flexion and Abduction will be measured using a handheld goniometer with the participant in a sitting position.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Adherence Rate
Attendance at exercise sessions
Measured: up to 8 weeks
Recruitment rate
The number of participants agreeing to participate divided by the total number eligible
Measured: 24 weeks
Adverse Event
Incidence of serious and non-serious adverse events will be recorded
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start14 Apr 2017
- Primary completion30 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group before and after intervention study design will be used for this pilot feasibility trial.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret McNeely, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084692
- Sponsor's protocol ID
- HREBA.CC-17-0049
- Acronym
- ASSURE
- Status last verified
- Apr 2018
- First submitted
- 14 Mar 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
- ClinicalTrials.gov ID
- NCT03084692
- Acronym / sponsor ID
- ASSURE / HREBA.CC-17-0049
- Conditions
- Lung Cancer
- Keywords
- caregiver, lung cancer, yoga, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group before and after intervention study design will be used for this pilot feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Yoga and Resistance Exercise | Experimental | Behavioral: Therapeutic Yoga and Resistance ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Yoga and Resistance ExerciseCombined Program of Yoga and Resistance Exercise | Behavioural | Therapeutic Yoga and Resistance Exercise |
Primary outcome
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.
12 secondary outcomes
Dyspnoea Visual Analogue Scale
Time frame: 8 weeks
Dyspnoea-12
Time frame: 8 weeks
Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)
Time frame: 8 weeks
Chest expansion (centimetres)
Time frame: 8 weeks
Shoulder Range of Motion (degrees)
Time frame: 8 weeks
Muscular strength
Time frame: 8 weeks
Pulmonary Function Testing
Time frame: 8 weeks
CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)
Time frame: 8 weeks
Chalder Fatigue Scale (Caregivers only)
Time frame: 8 weeks
Adherence Rate
Time frame: up to 8 weeks
Recruitment rate
Time frame: 24 weeks
Adverse Event
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: Undecided. Undecided at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McNeely principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Yoga and Resistance Exercise in people with Lung Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.