Home-based Exercise Training for Lung Cancer Patients Awaiting Surgery

NCT05473052 | Completed

• 1 other identifier: HomeFittosurgery
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Defined as the ratio of recruited patients to those who were eligible, expressed as a percentage.

  Baseline

• 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

• 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

• 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 Outcomes (9)

• Adverse events

  Baseline to 2-3 days before surgery

• Changes in exercise capacity

  Baseline to 2-3 days before surgery

• Changes in exercise capacity

  Baseline to 4-5 weeks after surgery.

• Changes in health-related quality of life

  Baseline to 2-3 days before surgery

• Changes in health-related quality of life

  Baseline to 4-5 weeks after surgery

Study Arms (1)

Preoperative home-based exercise training

EXPERIMENTAL

Patients received usual care plus a preoperative home-based exercise program consisting of aerobic and resistance exercise. In addition, a physical therapist carried out weekly telephone supervision with all participants

Behavioral: Preoperative home-based exercise training

Interventions

Preoperative home-based exercise training BEHAVIORAL

1\) Home-based aerobic and resistance exercise training (preoperative period) Dose of aerobic exercise: 1. Type: Walking 2. Frequency: 3 sessions per week 3. Duration: 30 minutes 4. Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5) 5. Progression: Increase the walking duration in 10 minutes (after week 2) Dose of resistance exercise: 1. Type: Six exercises for upper and lower limbs using bodyweight and free-wights of 1-2kg 2. Frequency: 2 sessions per week 3. Duration: 2 sets x 15 repetitions 4. Rest in-between sets: 45 seconds 5. Intensity:Rate of perceived exertion on Borg Category Ratio-10 (3-5) 6. 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.

Preoperative home-based exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead

Study Sites (1)

Portuguese Oncology Institute of Coimbra

Coimbra, 3000-075, Portugal

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 25, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

PT (1)