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Effect of Exercise Training in Lung Cancer

Primary Purpose

Lung Cancer, Nonsmall Cell

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic training
Pulmonary Exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Nonsmall Cell focused on measuring Nonsmall Cell Lung cancer, Chemotherapy, Exercise training

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Radiotherapy and Nuclear Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interventional Group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
December 13, 2021
Last Updated
April 4, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05158530
Brief Title
Effect of Exercise Training in Lung Cancer
Official Title
Effect Of Exercise Training In Patients With Lung Cancer During Chemotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell
Keywords
Nonsmall Cell Lung cancer, Chemotherapy, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Pulmonary exercises + Aerobic training, 40%-60% intensity 3 days/ week for 4 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Pulmonary exercises, 3 sessions per week and 3-5 repetitions in a session for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Pulmonary Exercises
Intervention Description
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 Outcome Measure Information:
Title
6 min walk test: Distance (meters)
Description
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.
Time Frame
4 weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
4 weeks
Title
Forced vital Capacity (FVC)
Description
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
4 weeks
Title
Rate of perceived exertion (RPE)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mindfulness
Description
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
Time Frame
4 weeks
Title
Hospital Anxiety and Depression
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Radiotherapy and Nuclear Medicine
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24975711
Citation
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.
Results Reference
background
PubMed Identifier
25350720
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.
Results Reference
background

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Effect of Exercise Training in Lung Cancer

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