Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Yoga and Resistance Exercise for Lung Cancer (ASSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084692
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Therapeutic Yoga and Resistance Exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group before and after intervention study design will be used for this pilot feasibility trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 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.

  9. 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.

  10. Adherence Rate [ Time Frame: up to 8 weeks ]
    Attendance at exercise sessions

  11. Recruitment rate [ Time Frame: 24 weeks ]
    The number of participants agreeing to participate divided by the total number eligible

  12. Adverse Event [ Time Frame: up to 24 weeks ]
    Incidence of serious and non-serious adverse events will be recorded



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084692


Locations
Layout table for location information
Canada, Alberta
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Investigators
Layout table for investigator information
Principal Investigator: Margaret McNeely University of Alberta

Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03084692    
Other Study ID Numbers: HREBA.CC-17-0049
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided at this time.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
caregiver
lung cancer
yoga
resistance exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases