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

4 mars 2019 uppdaterad av: Kathleen Lyons, Dartmouth-Hitchcock Medical Center

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756
        • Dartmouth-Hitchcock Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • This study will recruit English-speaking patients who:

    1. Are over the age of 18 and diagnosed with Stage I-III lung cancer;
    2. 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);
    3. 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);
    4. 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:

    1. Have a life expectancy of < 12 months or are receiving hospice services;
    2. 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;
    3. 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
    4. 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: single arm
exercise
Beteende: Exercise
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence to exercise:
Tidsram: Time 3, day of surgery
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Time 3, day of surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of recruitment:
Tidsram: Time 5, 16 weeks post-surgery
number of patients enrolled divided by number of patients eligible
Time 5, 16 weeks post-surgery
Acceptance of technology
Tidsram: Time 3, day of surgery
number of hours the fitness tracker was worn in pre-operative period
Time 3, day of surgery
Participant perception of exercise program
Tidsram: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the exercise program
Time 2, 3-5 days before surgery
Participant perception of fitness tracker
Tidsram: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the fitness tracker
Time 2, 3-5 days before surgery
Subjective minutes spent in exercise
Tidsram: Time 3, day of surgery
Number of minutes spent in exercise according to exercise log
Time 3, day of surgery
Objective minutes spent in exercise:
Tidsram: Time 3, day of surgery
Number of minutes spent in exercise according to fitness tracker
Time 3, day of surgery
Aerobic capacity:
Tidsram: Time 3, day of surgery
Six minute walk test
Time 3, day of surgery
Pulmonary function:
Tidsram: Time 2, 3-5 days before surgery
Diffusion of lungs for carbon monoxide test
Time 2, 3-5 days before surgery
Subjective physical function:
Tidsram: Time 2, 3-5 days before surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
Time 2, 3-5 days before surgery
Objective physical function:
Tidsram: Time 3, day of surgery
Grip strength per dynamometer
Time 3, day of surgery
Length of stay in hospital:
Tidsram: Time 4, 2 weeks post-surgery
Number of days from surgery to discharge home
Time 4, 2 weeks post-surgery
Feasibility of Retention
Tidsram: 16 weeks post-surgery
Number of patients completing all study assessments divided by the number enrolled
16 weeks post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbetspartners

Dartmouth College
Norris Cotton Cancer Center

Utredare

  • Huvudutredare: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center
  • Huvudutredare: David J Finley, MD, Dartmouth-Hitchcock Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 september 2017

Primärt slutförande (Faktisk)

5 februari 2019

Avslutad studie (Faktisk)

5 februari 2019

Studieregistreringsdatum

Först inskickad

4 maj 2017

Först inskickad som uppfyllde QC-kriterierna

19 maj 2017

Första postat (Faktisk)

22 maj 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 mars 2019

Senast verifierad

1 mars 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D17044

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

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