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NCT Number: NCT05158530

Effect of Exercise Training in Lung Cancer

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.

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Key information

Conditions

Lung Cancer, Nonsmall Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Radiotherapy and Nuclear Medicine

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aerobic training

Other

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

Pulmonary Exercises

Other

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)

Primary outcomes

  1. 6 min walk test: Distance (meters)

    Time frame: 4 weeks

    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.

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 4 weeks

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

  3. Forced vital Capacity (FVC)

    Time frame: 4 weeks

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

  4. Rate of perceived exertion (RPE)

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Mindfulness

    Time frame: 4 weeks

    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

  2. Hospital Anxiety and Depression

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2021
Registry last updated
Apr 6, 2022

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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