Effect of Exercise Training in Lung Cancer

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT05158530
Collaborator
(none)
40
1
2
3.4
11.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic training
  • Other: Pulmonary Exercises
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect Of Exercise Training In Patients With Lung Cancer During Chemotherapy Treatment
Actual Study Start Date :
Dec 20, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional Group

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

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

Placebo Comparator: Control group

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

Other: 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)

Outcome Measures

Primary Outcome Measures

  1. 6 min walk test: Distance (meters) [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) [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) [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) [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 Outcome Measures

  1. Mindfulness [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Radiotherapy and Nuclear Medicine Peshawar KPK Pakistan 25000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05158530
Other Study ID Numbers:
  • REC/01093 Muheebur Rehman
First Posted:
Dec 15, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022