None listed
Conditions
Brief summary
Brief description of the study purpose: This pilot study will examine the feasibility, safety and trends in effectiveness of providing a preoperative hospital and home-based rehabilitation program to individuals with stages I-IIIA Non-small cell lung cancer prior to surgery. The primary aim is to assess the feasibility of the prehabilitation program. Secondary aims are to assess postoperative outcomes (postoperative pulmonary complications and acute hospital Length of stay). Other secondary outcomes include changes in functional exercise capacity, physical activity levels, anxiety and depression and health-related quality of life. Who is it for? You may be eligible to participate in the study if you are over 18 years of age, have suspected stage I-IIIA lung cancer and are presenting for surgery and have no major comorbidities which would make exercise difficult. Study details: Participants will be randomly allocated to intervention or control groups. The intervention consists of preoperative exercise training (aerobic and resistance) for 1-4 weeks prior to lung cancer surgery. The control group will receive standard care (consisting of no preoperative exercise or physiotherapy intervention). It is hoped that this intervention will prove to be feasible and will improve postoperative outcomes, reduced hospital length of stay and improve the preoperative management of people with non-small cell lung cancer.
Interventions
Intervention (Prehabilitation group):
Participants allocated to the intervention group will receive a prehabilitation program prior to surgery. This includes resistance (free weights/ resistance band exercises for upper limb and lower limb) and aerobic training (walking, bike or treadmill) of moderate intensity designed and supervised by an experienced thoracic physiotherapist using exercise training principles. For between 1-4 weeks preoperatively, intervention participants will receive;
- hosp
Intervention (Prehabilitation group): Participants allocated to the intervention group will receive a prehabilitation program prior to surgery. This includes resistance (free weights/ resistance band exercises for upper limb and lower limb) and aerobic training (walking, bike or treadmill) of moderate intensity designed and supervised by an experienced thoracic physiotherapist using exercise training principles. For between 1-4 weeks preoperatively, intervention participants will receive; - hospital based supervised gym sessions (3x week, each 45 min duration), one-on-one - individualised home exercise program on days not attending hospital-based gym sessions and education regarding a home exercise program (exercise booklet + resistance exercise band designed specifically for this study) - 1-2 home visits - weekly phone calls to encourage home adherence - education: including lay information about lung cancer, the importance of staying active, diet and symptom control (e.g. breathlessness) given verbally in the initial consultation by the trial physiotherapist. This education will be provided once on the initial consultation, duration of the session will be approximately 15 minutes. - an exercise diary to record weekly exercise sessions The intervention will be individualised such that participants who opt not to attend the hospital gym sessions will be prescribed an exercise program (minimum 3x/week, 45min duration each session) to complete in their home with telephone and home visit follow-up. Participants will be given a stationary bike to use whilst exercising at home (if they do not already have one). Exercise intensity will be tailored to the individual and will utilise the BORG scale to monitor/progress as appropriate. The last exercise session for the intervention group will occur in the days preceding the surgery and may differ for each participant (dependant on the day of surgery). Exercise sessions are flexible in that they can be completed on subsequent or alternate days, at the discretion of the participant. Participants will receive standard post-operative care consisting of a thoracic surgery clinical pathway.
Sponsors
St Vincents Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: - suspected stage I-IIIA NSCLC presenting for surgical consult - age > 18 years - functional exercise capacity < 70% predicted (6MWT) (recruiting those who are most likely to benefit - primary treating surgeon approval
Exclusion criteria
Exclusion criteria: - unstable psychiatric/cognitive disorder - major comorbidities preventing participation in the exercise - unable to give informed consent - non-english speaking
Outcome results
None listed