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Trial Title:
Prehabilitation and RecOVERy From Surgery for Breast Cancer Study
NCT ID:
NCT05901142
Condition:
Exercise
Breast Neoplasm Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise-based multi-phasic, multi-modal intervention
Description:
Pre-op: 2*60min supervised; 1*30min unsupervised walking sessions per week Supervised
session: Aerobic: 8*60secs star jump, squat thrust, high knees with 90sec rest. Elastic
resistance: 2*10-12reps of chest press, seated row, leg press, 'lat' pulldown, and either
abdominal flexion or lumbar extension-alternated, with 60-90sec rest. Targeted
physiotherapy: general breathing exercises, active-assisted range of motion (RoM)
exercises, and active-resisted RoM exercises
Postop: 1*60min supervised exercise; unsupervised walking [2*30min weeks 1-2; 3*30min
week 3; 4*30min weeks 4-6] session per week Supervised session: Aerobic: As above using
full body extension, squat jump, static sprint in week 1-4. Progressed to those performed
preoperatively from week 5. Elastic resistance: As above from week 4, performed 3*week.
Targeted physiotherapy: As above, with active-assisted RoM progressing from 1*10reps in
week 1, to 2*10reps in weeks 2-4, and 3*10reps in weeks 4-6
Arm group label:
Exercise-based multi-phasic, multi-modal intervention
Summary:
Background and study aims:
Nine out of ten women experience some negative effects due to their disease or its
treatment such as anxiety, depression, weight gain and low quality of life. Research
shows that exercise may help women overcome some of these effects. The investigators also
know that most women become physically inactive after cancer treatment. Therefore, The
investigators feel it is important that women get into a routine of doing regular
exercise before they start their cancer treatment, this is called prehabilitation. The
investigators believe that prehabilitation might help to build confidence and help women
to continue exercising after their cancer treatment.
The investigators are doing this study to find out if a remote (NHS Attend Anywhere),
multimodal (aerobic, resistance and targeted exercise), behavioural change (Health Action
Process Approach (HAPA), dyadic coping (the collective effort to dealing with the stress
of breast cancer diagnosis and treatment), and wearable technology), multiphasic (pre-
and post-surgery) intervention is feasible in the short time frame between diagnosis of
breast cancer and surgery (less than 31 days). The investigators would also like to find
out whether it is feasible for women to begin an exercise rehabilitation programme two
weeks after their operation. If successful, the results will potentially enable us in the
future to tailor the support gievn to women to help them prepare and recover from breast
cancer treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Females aged 18 years or older
- Scheduled to undergo elective surgery for biopsy-proven breast cancer (lumpectomy or
mastectomy) for resection and/or reconstruction purposes
- Patients scheduled after diagnosis of invasive breast cancer and ductal carcinoma in
situ (DCIS)
- Able to communicate in English and able to provide and understand informed consent
- Willing to participate in supervised and home-based exercise
- Have the approval of operating surgeon
- At least 2 weeks until surgery
- Access to a computer or smart device connected to the world wide web
Exclusion Criteria:
- Evidence in the medical record of an absolute contraindication for exercise [e.g.,
Heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia;
uncontrolled hypertension; severe renal dysfunction (Estimated Glomerular Filtration
Rate (eGFR) < 30%, Creatinine> 3 mg/dl); insufficient haematological capacity like
either haemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced
standing or walking ability].
- Metastatic breast cancer
- Current smokers
- Not fluent in written and spoken English
- Engaging in regular exercise (at least 150 min per week of moderate exercise or at
least 75 min per week of vigorous exercise, or an equivalent combination of moderate
and vigorous exercise). This criterion will be assessed via the Physical Activity
Vital Signs (PAVS) questionnaire, which asks the following two questions: 1) "Please
describe your level of physical activity, [first by] minutes per day, [followed by]
number of days each week", and 2) "At what intensity (how hard): light (like a
casual walk), moderate (like a brisk walk), or vigorous (like a jog/run)?" (Ball et
al., 2016). The questionnaire is scored by multiplying the days by minutes of
physical activity to create an estimate of minutes per week of at least
moderate-to-vigorous physical activity.
- Symptoms of long-covid/post covid syndrome
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Derby and Burton
Address:
City:
Burton Upon Trent
Country:
United Kingdom
Start date:
June 16, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University Hospitals of Derby and Burton NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Wolverhampton
Agency class:
Other
Collaborator:
Agency:
University of Hull
Agency class:
Other
Collaborator:
Agency:
Sheffield Teaching Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Bath
Agency class:
Other
Collaborator:
Agency:
Aston University
Agency class:
Other
Collaborator:
Agency:
Staffordshire University
Agency class:
Other
Source:
University Hospitals of Derby and Burton NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901142
