A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
4 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: single arm
exercise
|
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence to exercise:
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of recruitment:
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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:
Délai: Time 3, day of surgery
|
Number of minutes spent in exercise according to fitness tracker
|
Time 3, day of surgery
|
|
Aerobic capacity:
Délai: Time 3, day of surgery
|
Six minute walk test
|
Time 3, day of surgery
|
|
Pulmonary function:
Délai: Time 2, 3-5 days before surgery
|
Diffusion of lungs for carbon monoxide test
|
Time 2, 3-5 days before surgery
|
|
Subjective physical function:
Délai: 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:
Délai: Time 3, day of surgery
|
Grip strength per dynamometer
|
Time 3, day of surgery
|
|
Length of stay in hospital:
Délai: Time 4, 2 weeks post-surgery
|
Number of days from surgery to discharge home
|
Time 4, 2 weeks post-surgery
|
|
Feasibility of Retention
Délai: 16 weeks post-surgery
|
Number of patients completing all study assessments divided by the number enrolled
|
16 weeks post-surgery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center
- Chercheur principal: David J Finley, MD, Dartmouth-Hitchcock Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 septembre 2017
Achèvement primaire (Réel)
5 février 2019
Achèvement de l'étude (Réel)
5 février 2019
Dates d'inscription aux études
Première soumission
4 mai 2017
Première soumission répondant aux critères de contrôle qualité
19 mai 2017
Première publication (Réel)
22 mai 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D17044
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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