A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients

NCT ID: NCT04826835

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2025-06-01

Brief Summary

This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Prehabilitation intervention

Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.

Group Type: EXPERIMENTAL

Prehabilitation intervention

Intervention Type: BEHAVIORAL

Participants will:

• Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist;
• Practice six sessions of home-based exercise (three times per week for two weeks);
• Practice unsupervised respiratory muscle training at home (twice daily for two weeks);
• Receive usual care.

Health education control

Participants in the control group will receive health education classes during 2 weeks before lung resection.

Group Type: ACTIVE_COMPARATOR

Health education control

Intervention Type: BEHAVIORAL

Participants will:

• Receive four recorded health education talks (twice per week for two weeks)
• Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery
• Receive usual care.

Interventions

Prehabilitation intervention

Participants will:

• Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist;
• Practice six sessions of home-based exercise (three times per week for two weeks);
• Practice unsupervised respiratory muscle training at home (twice daily for two weeks);
• Receive usual care.

Intervention Type: BEHAVIORAL

Health education control

Participants will:

• Receive four recorded health education talks (twice per week for two weeks)
• Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery
• Receive usual care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation

2. Patients scheduled to undergo lung resection surgery at least two weeks from recruitment

3. Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment

4. Patients with no evidence of recurrent or progressive disease

5. Patients aged 45-80 years

6. Patients able to communicate in Cantonese, Mandarin, or English

7. Patients is absence of any cognitive impairment

8. Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. [rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection]

9. Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months

Exclusion Criteria

1. Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months

2. Presence of another concurrent, actively treated malignancy

3. Presence of chronic obstructive pulmonary disease

4. Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living

5. Not having a smart device to receive WhatsApp messages

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Chia-Chin Lin

Professor and Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Chia-chin Lin, PhD

Role: CONTACT

cclin@hku.hk

39176614

Xinyi Xu, BSN

Role: CONTACT

xuxinyi@connect.hku.hk

39176948

Other Identifiers

UW 19-214

Identifier Type: -

Identifier Source: org_study_id