Prehabilitation and RecOVERy From Surgery for Breast Cancer Study

NCT05901142 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

  • Exercise
  • Breast Neoplasm Female

Interventions

BEHAVIORAL

Exercise-based multi-phasic, multi-modal intervention

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

Sponsors & Collaborators

  • University of Wolverhampton

    collaborator OTHER
  • University of Hull

    collaborator OTHER
  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • University of Bath

    collaborator OTHER
  • Aston University

    collaborator OTHER
  • Staffordshire University

    collaborator OTHER
  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amtul Carmichael · University Hospitals of Derby and Burton NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901142 on ClinicalTrials.gov