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Completed

NCT Number: NCT03162718

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

The investigators propose a parallel mixed methods, 16 single arm, pre-post study with 30 participants scheduled for lung cancer surgery. At time of enrollment (at least 3 weeks before their scheduled surgery), participants will complete baseline assessments, receive the uPEP exercise prescription, and be oriented to the wearable fitness device. A research assistant will call the participant to conduct an audiotaped semi-structured interview regarding the acceptability of the electronically-monitored uPEP within 7- 14 days of enrollment. The study team will complete follow-up assessments on the day of surgery, two weeks after surgery, and four months after surgery. Data will also be collected from chart review and the wearable fitness device throughout the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Adherence to exercise:

    Time frame: Time 3, day of surgery

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

Secondary outcomes

  1. Feasibility of recruitment:

    Time frame: Time 5, 16 weeks post-surgery

    number of patients enrolled divided by number of patients eligible

  2. Acceptance of technology

    Time frame: Time 3, day of surgery

    number of hours the fitness tracker was worn in pre-operative period

  3. Participant perception of exercise program

    Time frame: Time 2, 3-5 days before surgery

    semi-structured interview regarding perceptions of the exercise program

  4. Participant perception of fitness tracker

    Time frame: Time 2, 3-5 days before surgery

    semi-structured interview regarding perceptions of the fitness tracker

  5. Subjective minutes spent in exercise

    Time frame: Time 3, day of surgery

    Number of minutes spent in exercise according to exercise log

  6. Objective minutes spent in exercise:

    Time frame: Time 3, day of surgery

    Number of minutes spent in exercise according to fitness tracker

  7. Aerobic capacity:

    Time frame: Time 3, day of surgery

    Six minute walk test

  8. Pulmonary function:

    Time frame: Time 2, 3-5 days before surgery

    Diffusion of lungs for carbon monoxide test

  9. Subjective physical function:

    Time frame: Time 2, 3-5 days before surgery

    PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale

  10. Objective physical function:

    Time frame: Time 3, day of surgery

    Grip strength per dynamometer

  11. Length of stay in hospital:

    Time frame: Time 4, 2 weeks post-surgery

    Number of days from surgery to discharge home

  12. Feasibility of Retention

    Time frame: 16 weeks post-surgery

    Number of patients completing all study assessments divided by the number enrolled

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • Norris Cotton Cancer Center

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 22, 2017
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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