Home-based Exercise Training for Lung Cancer Patients Awaiting Surgery

Lung Neoplasm Clinical Trial

Official title:

Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery: A Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473052
• Other study ID #: HomeFittosurgery
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Instituto Politécnico de Leiria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary complications.

Although current clinical guidelines strongly recommend preoperative exercise training to improve clinical outcomes after lung cancer surgery, inaccessibility to facility-based exercise programs is a major barrier to routine participation, with patients indicating a strong preference to exercise in a home-based environment.

The primary purpose of the present study was to evaluate the feasibility of a home-based exercise program (HBEP) in lung cancer patients awaiting surgical treatment. The secondary purposes were to evaluate the safety of the HBEP and to explore exercise effects on patients' HRQOL and physical performance, either pre-and post-surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)

• Waiting time for surgery of at least two weeks from baseline assessment

• Medical clearance to exercise.

• Signed informed consent prior to initiation of study-related procedures.

Exclusion Criteria:

• Metastatic cancer

• Presence of physical or mental disabilities that contraindicated exercise training or physical testing

• Unable to communicate in Portuguese or English

• Performing combined aerobic plus resistance training over the past month (self-reported =2 days a week, =30 minutes each session).

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Behavioral:
• Preoperative home-based exercise training
1) Home-based aerobic and resistance exercise training (preoperative period) Dose of aerobic exercise: Type: Walking Frequency: 3 sessions per week Duration: 30 minutes Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5) Progression: Increase the walking duration in 10 minutes (after week 2) Dose of resistance exercise: Type: Six exercises for upper and lower limbs using bodyweight and free-wights of 1-2kg Frequency: 2 sessions per week Duration: 2 sets x 15 repetitions Rest in-between sets: 45 seconds Intensity:Rate of perceived exertion on Borg Category Ratio-10 (3-5) Progression: Increase the number of sets (3 sets of 15 repetitions after week 2) Weekly telephone supervision: A physical therapist carried out weekly telephone calls with all participants to monitor adverse events, give positive reinforcement and recommend strategies to overcome barriers that arise during the exercise program.

Locations

Country	Name	City	State
Portugal	Portuguese Oncology Institute of Coimbra	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Politécnico de Leiria

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Defined as the ratio of recruited patients to those who were eligible, expressed as a percentage.	Baseline
Primary	Retention rate	Defined as the ratio of patients who completed the study to those who were recruited, expressed as a percentage	Baseline to 4-5 weeks after surgery
Primary	Exercise attendance rate	Attendance rate will be defined as the ratio of total completed to planned exercise sessions, expressed as a percentage.	Baseline to 2-3 days before surgery
Primary	Exercise compliance rate	Compliance rate will be defined as the ratio of total completed to planned training volume, expressed as a percentage.	Baseline to 2-3 days before surgery
Secondary	Adverse events	Defined as any unfavorable or unexpected event that occurred as a direct result of exercise training, during or within 24 hours after an exercise session. The severity of adverse events was categorized based on the Common Terminology Criteria for Adverse Events (CTCAE), version 5. The CTCAE provides a grading (severity) scale, with each adverse event been classified as grade 1 (asymptomatic or mild symptoms, clinical or diagnostic observations only, and/or intervention not indicated) to grade 5 (death). An adverse event was classified as "serious" if it resulted in hospitalization, persistent or significant disability, was life threatening, or resulted in death (i.e., grade 3 or higher).	Baseline to 2-3 days before surgery
Secondary	Changes in exercise capacity	Assessed by the Incremental Shuttle Walk Test (ISWT). The ISWT measures the distance in meters an individual can walk around a 10 meters shuttle course paced according to an incremental speed dictated by an audio recording and was performed under the supervision of a single investigator using the protocol described by Singh et al.; (1992). The test finished when the participant can no longer maintain the desired speed or became too breathless to continue.	Baseline to 2-3 days before surgery
Secondary	Changes in exercise capacity	Assessed by the Incremental Shuttle Walk Test (ISWT). The ISWT measures the distance in meters an individual can walk around a 10 meters shuttle course paced according to an incremental speed dictated by an audio recording and was performed under the supervision of a single investigator using the protocol described by Singh et al.; (1992). The test finished when the participant can no longer maintain the desired speed or became too breathless to continue.	Baseline to 4-5 weeks after surgery.
Secondary	Changes in health-related quality of life	Assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) (version 3.0). The QLQ-C30 is composed of 30 questions, including five multi-item functioning scales, three multi-item symptom scales, six single-item symptom scales, and a two-item global health status scale [GHS]. Scores range from 0 to 100 points, with a higher score on the functioning scales indicating a higher level of functioning, whereas a higher score on the symptom scales indicates a higher level of symptom burden.; In addition, was assessed the EORTC QLQ-C30 summary score (SumSc) because it provides a psychometrically more robust alternative to the GHS score that is frequently used as the primary HRQOL endpoint in clinical trials. The SumSc is calculated from the mean of 13 of the 15 QLQ-C30 scores (the GHS and financial impact scales are excluded).	Baseline to 2-3 days before surgery
Secondary	Changes in health-related quality of life	Assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) (version 3.0). The QLQ-C30 is composed of 30 questions, including five multi-item functioning scales, three multi-item symptom scales, six single-item symptom scales, and a two-item global health status scale [GHS]. Scores range from 0 to 100 points, with a higher score on the functioning scales indicating a higher level of functioning, whereas a higher score on the symptom scales indicates a higher level of symptom burden.; In addition, was assessed the EORTC QLQ-C30 summary score (SumSc) because it provides a psychometrically more robust alternative to the GHS score that is frequently used as the primary HRQOL endpoint in clinical trials. The SumSc is calculated from the mean of 13 of the 15 QLQ-C30 scores (the GHS and financial impact scales are excluded).	Baseline to 4-5 weeks after surgery
Secondary	Changes in handgrip strength	Assessed using a Jamar hydraulic hand dynamometer (JA Preston Corporation, Jackson, MI, USA). Measurements were conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer was set at the second handle position for all patients. The non-tested arm was resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients were instructed to grip the handle with maximal strength during 3 seconds and the measurements were repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) was considered as the output measure to each patient.	Baseline to 2-3 days before surgery
Secondary	Changes in handgrip strength	Assessed using a Jamar hydraulic hand dynamometer (JA Preston Corporation, Jackson, MI, USA). Measurements were conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer was set at the second handle position for all patients. The non-tested arm was resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients were instructed to grip the handle with maximal strength during 3 seconds and the measurements were repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) was considered as the output measure to each patient.	Baseline to 4-5 weeks after surgery
Secondary	Changes in five times sit to stand test	Patients were instructed to perform the Five Times Sit to Stand Test (5STS) on a standardized armless chair (i.e., seating height between 41-45 cm, no elbow rests and wheels). After the cue "ready, set, go!", patients started the STS repetitions as rapidly as possible from the sitting position with their buttocks touching the chair to the full standing position, with their arms crossed over the chest. The 5STS test finished when the patients sit on the chair after the fifth repetition, and the time needed to complete the task was recorded with a stopwatch to the nearest 0.01 s.	Baseline to 2-3 days before surgery
Secondary	Changes in five times sit to stand test	Patients were instructed to perform the Five Times Sit to Stand Test (5STS) on a standardized armless chair (i.e., seating height between 41-45 cm, no elbow rests and wheels). After the cue "ready, set, go!", patients started the STS repetitions as rapidly as possible from the sitting position with their buttocks touching the chair to the full standing position, with their arms crossed over the chest. The 5STS test finished when the patients sit on the chair after the fifth repetition, and the time needed to complete the task was recorded with a stopwatch to the nearest 0.01 s.	Baseline to 4-5 weeks after surgery