Effect of Exercise Training in Lung Cancer

Study Overview
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Brief Summary
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To determine the effects of exercise training in patients with lung cancer during chemotherapy treatment. In currently accessible literature, majority studies, met-analysis, and systemic reviews are related to surgical procedures and post-op pulmonary Rehabilitation of patients with Lung cancer. In literature, Gap related to the control group was observed also. The current study aimed to fulfill this gap by planning a structured intervention plan for the control group as well. It will also add in literature the deficiency of oncology rehab for patients receiving chemotherapy only.

Detailed Description
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Literature suggested that a pulmonary rehabilitation program for patients with non-small cell lung cancer undergoing induction chemo-radiotherapy seems to improve respiratory function. It is particularly recommended for smokers and patients with respiratory impairment.

Official Title
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Effect Of Exercise Training In Patients With Lung Cancer During Chemotherapy Treatment

Conditions
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Lung Cancer, Nonsmall Cell

Intervention / Treatment
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* Other: Aerobic training
* Other: Pulmonary Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosed patients of stage 1 and 2 Non-small cell lung carcinoma (NSCLC) including Adenocarcinoma & squamous cell carcinoma The diagnosis was established within 6 wk prior to enrollment and was confirmed by histology. Participants are undergoing lung cancer chemotherapy Participant has the willingness to participate in training WHO physical fitness scores 0-1 Able to perform 6-minute walk test (6MWT) at baseline Exclusion Criteria: • Participant with history of trauma and surgery Patients with lung disease other than lung cancer Uncontrolled hypertension or unstable coronary artery disease. Severe OA, bone or CNS metastases. hemoglobin <10 g/dL Lower than 3,500 white blood cells per microliter of blood

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>Pulmonary exercises + Aerobic training, 40%-60% intensity 3 days/ week for 4 weeks | Other: Aerobic training<br>* Aerobic training ( with cycle ergometer, 5-minute warm-up 15 - 30 minute cycle +5 minute cooldown) 40%-60% intensity calculated through Karvonen formula 3 days/ week<br>|
| Placebo Comparator: Control group<br>Pulmonary exercises, 3 sessions per week and 3-5 repetitions in a session for 4 weeks. | Other: Pulmonary Exercises<br>* 4 weeks protocol Deep breathing Exercises* 10 Reps 3 sets Postural drainage (10 minutes * 2 sets /day) Incentive spirometry* 10 Reps 3 sets Bed activities (Active ankle and hand pumping exercise * 10 Reps 3 sets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 min walk test: Distance (meters) | Changes from the baseline, 6 min walk test (6 MWT) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support. | 4 weeks | 
| Forced Expiratory Volume in 1 second (FEV1) | Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters | 4 weeks | 
| Forced vital Capacity (FVC) | Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters | 4 weeks | 
| Rate of perceived exertion (RPE) | Changes From the Baseline, measured through Borg RPE scale which measures a person's perception of their effort and exertion breathlessness, and fatigue during physical work rating between 1 and 10. The higher the number, the more intense the exercise. An RPE of 1 is often referred to as just above rest, hardly any exertion, while an RPE of 10 is a maximal effort. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindfulness | Changes From the Baseline, measured through MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The scale shows strong psychometric properties and has been validated with college, community, and cancer patient samples.Higher scores reflect higher levels of dispositional mindfulness | 4 weeks | 
| Hospital Anxiety and Depression | The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonsmall Cell Lung cancer, Chemotherapy, Exercise training