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

4. mars 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth-Hitchcock Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: single arm
exercise
Atferdsmessig: Exercise
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to exercise:
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of recruitment:
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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:
Tidsramme: Time 3, day of surgery
Number of minutes spent in exercise according to fitness tracker
Time 3, day of surgery
Aerobic capacity:
Tidsramme: Time 3, day of surgery
Six minute walk test
Time 3, day of surgery
Pulmonary function:
Tidsramme: Time 2, 3-5 days before surgery
Diffusion of lungs for carbon monoxide test
Time 2, 3-5 days before surgery
Subjective physical function:
Tidsramme: 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:
Tidsramme: Time 3, day of surgery
Grip strength per dynamometer
Time 3, day of surgery
Length of stay in hospital:
Tidsramme: Time 4, 2 weeks post-surgery
Number of days from surgery to discharge home
Time 4, 2 weeks post-surgery
Feasibility of Retention
Tidsramme: 16 weeks post-surgery
Number of patients completing all study assessments divided by the number enrolled
16 weeks post-surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbeidspartnere

Dartmouth College
Norris Cotton Cancer Center

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. september 2017

Primær fullføring (Faktiske)

5. februar 2019

Studiet fullført (Faktiske)

5. februar 2019

Datoer for studieregistrering

Først innsendt

4. mai 2017

Først innsendt som oppfylte QC-kriteriene

19. mai 2017

Først lagt ut (Faktiske)

22. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D17044

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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