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Completed

NCT Number: NCT03084692

Therapeutic Yoga and Resistance Exercise for Lung Cancer

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Yoga and Resistance Exercise

Behavioral

Combined Program of Yoga and Resistance Exercise

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: ASSURE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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