A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery

NCT03162718 | Completed DMC

• 1 other identifier: D17044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is increasingly promoted within general surgery and surgical oncology. Patients with lung cancer participating in pre-operative exercise have better aerobic capacity and pulmonary function and shorter hospital length-of-stay after surgery. Additionally, pre-operative exercise may increase the likelihood of resuming exercise post-surgery, thereby accelerating the pace of rehabilitation and recovery. In order to translate the research findings into sustainable clinical practice, clinician-scientists need to develop pragmatic and effective home-based exercise protocols. Wearable fitness devices offer a way to approximate the supervision that occurs in exercise research. Before the investigators can develop an intervention in which patients receive tailored support similar to what occurs with supervised exercise, they need to pilot test the monitoring aspect of the wearable fitness device in conjunction with the pre-operative exercise program. The investigators propose a mixed methods, 16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.

Conditions

Lung Cancer

Keywords

lung cancer; exercise; pre-operative exercise program

Outcome Measures

Primary Outcomes (1)

• Adherence to exercise:

  number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log

  Time 3, day of surgery

Secondary Outcomes (12)

• Feasibility of recruitment:

  Time 5, 16 weeks post-surgery

• Acceptance of technology

  Time 3, day of surgery

• Participant perception of exercise program

  Time 2, 3-5 days before surgery

• Participant perception of fitness tracker

  Time 2, 3-5 days before surgery

• Subjective minutes spent in exercise

  Time 3, day of surgery

Study Arms (1)

single arm

OTHER

exercise

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will recruit English-speaking patients who:
• Are over the age of 18 and diagnosed with Stage I-III lung cancer;
• Are able to tolerate surgery (i.e., segmentectomy, lobectomy or bilobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation (if indicated);
• Access to either Wi-Fi or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team);
• Are able to provide voluntary, written consent.

You may not qualify if:

• Participants will be excluded based on electronic health record (EHR) review (after obtaining HIPAA waiver) if they:
• Have a life expectancy of \< 12 months or are receiving hospice services;
• Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
• Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of \>120bpm, blood pressure \>180/100mmHg or unstable angina;31
• Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Norris Cotton Cancer Center: collaborator
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Finley DJ, Stevens CJ, Emond JA, Batsis JA, Fay KA, Darabos C, Sacks OA, Cook SB, Lyons KD. Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients. Surg Oncol. 2021 Jun;37:101525. doi: 10.1016/j.suronc.2021.101525. Epub 2021 Mar 5.

  PMID: 33813267 DERIVED

• Finley DJ, Fay KA, Batsis JA, Stevens CJ, Sacks OA, Darabos C, Cook SB, Lyons KD. A feasibility study of an unsupervised, pre-operative exercise program for adults with lung cancer. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13254. doi: 10.1111/ecc.13254. Epub 2020 May 29.

  PMID: 32469129 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathleen D Lyons, ScD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• David J Finley, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, Psychiatry Research

Model Details: The investigators propose a mixed methods,16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 22, 2017
• Study Start: September 14, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

US (1)