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Therapeutic Yoga and Resistance Exercise for Lung Cancer (ASSURE)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Therapeutic Yoga and Resistance Exercise
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring caregiver, lung cancer, yoga, resistance exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alberta/ Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Yoga and Resistance Exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Completion Rate
Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.

Secondary Outcome Measures

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.
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.
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.
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.
Shoulder Range of Motion (degrees)
Active Flexion and Abduction will be measured using a handheld goniometer with the participant in a sitting position.
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.
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.
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.
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.
Adherence Rate
Attendance at exercise sessions
Recruitment rate
The number of participants agreeing to participate divided by the total number eligible
Adverse Event
Incidence of serious and non-serious adverse events will be recorded

Full Information

First Posted
March 14, 2017
Last Updated
October 12, 2018
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03084692
Brief Title
Therapeutic Yoga and Resistance Exercise for Lung Cancer
Acronym
ASSURE
Official Title
Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
caregiver, lung cancer, yoga, resistance exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group before and after intervention study design will be used for this pilot feasibility trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Yoga and Resistance Exercise
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Therapeutic Yoga and Resistance Exercise
Intervention Description
Combined Program of Yoga and Resistance Exercise
Primary Outcome Measure Information:
Title
Completion Rate
Description
Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Dyspnoea Visual Analogue Scale
Description
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.
Time Frame
8 weeks
Title
Dyspnoea-12
Description
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.
Time Frame
8 weeks
Title
Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)
Description
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.
Time Frame
8 weeks
Title
Chest expansion (centimetres)
Description
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.
Time Frame
8 weeks
Title
Shoulder Range of Motion (degrees)
Description
Active Flexion and Abduction will be measured using a handheld goniometer with the participant in a sitting position.
Time Frame
8 weeks
Title
Muscular strength
Description
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.
Time Frame
8 weeks
Title
Pulmonary Function Testing
Description
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.
Time Frame
8 weeks
Title
CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)
Description
The CareGiver Oncology Quality of Life (CarGOQoL) questionnaire is a 29-item, multidimensional, self-administered questionnaire.
Time Frame
8 weeks
Title
Chalder Fatigue Scale (Caregivers only)
Description
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.
Time Frame
8 weeks
Title
Adherence Rate
Description
Attendance at exercise sessions
Time Frame
up to 8 weeks
Title
Recruitment rate
Description
The number of participants agreeing to participate divided by the total number eligible
Time Frame
24 weeks
Title
Adverse Event
Description
Incidence of serious and non-serious adverse events will be recorded
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret McNeely
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta/ Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided at this time.

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Therapeutic Yoga and Resistance Exercise for Lung Cancer

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