Therapeutic Yoga and Resistance Exercise for Lung Cancer (ASSURE)
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|ClinicalTrials.gov Identifier: NCT03084692|
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Behavioral: Therapeutic Yoga and Resistance Exercise||Not Applicable|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Adherence Rate [ Time Frame: up to 8 weeks ]Attendance at exercise sessions
- Recruitment rate [ Time Frame: 24 weeks ]The number of participants agreeing to participate divided by the total number eligible
- Adverse Event [ Time Frame: up to 24 weeks ]Incidence of serious and non-serious adverse events will be recorded
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
|University of Alberta/ Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 2G4|
|Principal Investigator:||Margaret McNeely||University of Alberta|