Effect of Exercise Training in Lung Cancer

NCT05158530 | Completed DMC

• 1 other identifier: REC/01093 Muheebur Rehman
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer, Nonsmall Cell

Keywords

Nonsmall Cell Lung cancer, Chemotherapy, Exercise training

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mindfulness

  4 weeks

• Hospital Anxiety and Depression

  4 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

Pulmonary exercises + Aerobic training, 40%-60% intensity 3 days/ week for 4 weeks

Other: Aerobic training

Control group

PLACEBO COMPARATOR

Pulmonary exercises, 3 sessions per week and 3-5 repetitions in a session for 4 weeks.

Other: Pulmonary Exercises

Interventions

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

Interventional Group

Pulmonary Exercises OTHER

4 weeks protocol 1. Deep breathing Exercises\* 10 Reps 3 sets 2. Postural drainage (10 minutes \* 2 sets /day) 3. Incentive spirometry\* 10 Reps 3 sets 4. Bed activities (Active ankle and hand pumping exercise \* 10 Reps 3 sets)

Control group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Institute of Radiotherapy and Nuclear Medicine

Peshawar, KPK, 25000, Pakistan

Location

Related 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.

  PMID: 24975711 BACKGROUND

• 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.

  PMID: 25350720 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mehwish Waseem, MSPT(CPPT)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 15, 2021
• Study Start: December 20, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)