Back to resultsA Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Prehabilitation intervention
Health education control
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Prehabilitation, Physical activity, Lung resection, Functional capacity
Eligibility Criteria
Inclusion Criteria:
- Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
- Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
- Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
- Patients with no evidence of recurrent or progressive disease
- Patients aged 18 or above
- Patients able to communicate in Cantonese, Mandarin, or English
- Patients is absence of any cognitive impairment
- 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]
Exclusion Criteria:
- 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
- Presence of another concurrent, actively treated malignancy
- Presence of chronic obstructive pulmonary disease
- 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
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prehabilitation intervention
Health education control
Arm Description
Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.
Participants in the control group will receive health education classes during 2 weeks before lung resection.
Outcomes
Primary Outcome Measures
Change from baseline 6-minute walking distance at 1-month post-surgery
Secondary Outcome Measures
Change from baseline 6-minute walking distance at post-intervention
Change from baseline 6-minute walking distance at 6-months post-surgery
Length of postoperative hospital stay
Postoperative complication
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 6-months post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
Change from baseline international physical activity questionnaire (IPAQ) at 6-months post-surgery
Change from baseline daily step count measured by pedometer at post-intervention
Change from baseline daily step count measured by pedometer at 1-month post-surgery
Change from baseline daily step count measured by pedometer at 6-months post-surgery
Full Information
NCT ID
NCT04826835
First Posted
March 23, 2021
Last Updated
March 17, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04826835
Brief Title
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
Official Title
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Prehabilitation, Physical activity, Lung resection, Functional capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation intervention
Arm Type
Experimental
Arm Description
Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.
Arm Title
Health education control
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive health education classes during 2 weeks before lung resection.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation intervention
Intervention Description
Participants will:
Receive four supervised exercise classes (twice per week for two weeks);
Practice six sessions of home-based exercise (three times per week for two weeks);
Practice unsupervised respiratory muscle training (daily for two weeks);
Receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Health education control
Intervention Description
Participants will:
Receive four health education talks (twice per week for two weeks)
Receive usual care.
Primary Outcome Measure Information:
Title
Change from baseline 6-minute walking distance at 1-month post-surgery
Time Frame
Baseline; 1-month post-surgery
Secondary Outcome Measure Information:
Title
Change from baseline 6-minute walking distance at post-intervention
Time Frame
Baseline; 2 weeks (post-intervention)
Title
Change from baseline 6-minute walking distance at 6-months post-surgery
Time Frame
Baseline; 6-months post-surgery
Title
Length of postoperative hospital stay
Time Frame
1-month post-surgery
Title
Postoperative complication
Time Frame
1-month post-surgery
Title
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention
Time Frame
Baseline; 2 weeks (post-intervention)
Title
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery
Time Frame
Baseline; 1-month post-surgery
Title
Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 6-months post-surgery
Time Frame
Baseline; 6-months post-surgery
Title
Change from baseline international physical activity questionnaire (IPAQ) at post-intervention
Time Frame
Baseline; 2 weeks (post-intervention)
Title
Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery
Time Frame
Baseline; 1-months post-surgery
Title
Change from baseline international physical activity questionnaire (IPAQ) at 6-months post-surgery
Time Frame
Baseline; 6-month post-surgery
Title
Change from baseline daily step count measured by pedometer at post-intervention
Time Frame
Baseline; 2 weeks (post-intervention)
Title
Change from baseline daily step count measured by pedometer at 1-month post-surgery
Time Frame
Baseline; 1-months post-surgery
Title
Change from baseline daily step count measured by pedometer at 6-months post-surgery
Time Frame
Baseline; 6-months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
Patients with no evidence of recurrent or progressive disease
Patients aged 18 or above
Patients able to communicate in Cantonese, Mandarin, or English
Patients is absence of any cognitive impairment
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]
Exclusion Criteria:
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
Presence of another concurrent, actively treated malignancy
Presence of chronic obstructive pulmonary disease
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-chin Lin, PhD
Phone
39176614
Email
cclin@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyi Xu, BSN
Phone
39176948
Email
xuxinyi@connect.hku.hk
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
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