Effect of Exercise Training in Lung Cancer

Lung Cancer, Nonsmall Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158530
• Other study ID #: REC/01093 Muheebur Rehman
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

Intervention

Other:
• Aerobic training
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
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)

Locations

Country	Name	City	State
Pakistan	Institute of Radiotherapy and Nuclear Medicine	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Davis KM, Kelly SP, Luta G, Tomko C, Miller AB, Taylor KL. The association of long-term treatment-related side effects with cancer-specific and general quality of life among prostate cancer survivors. Urology. 2014 Aug;84(2):300-6. doi: 10.1016/j.urology.2014.04.036. Epub 2014 Jun 26. — View Citation

Vainshelboim B, Fox BD, Saute M, Sagie A, Yehoshua L, Fuks L, Schneer S, Kramer MR. Limitations in exercise and functional capacity in long-term postpneumonectomy patients. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):56-64. doi: 10.1097/HCR.0000000000000085. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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