Exercise Interventions for Improving Health in Breast Cancer Survivors

NCT06376578 | Completed

• 1 other identifier: 245256
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Change in VO2max (maximum oxygen uptake)

  Measure of cardiorespiratory fitness

  9 weeks

Secondary Outcomes (1)

• Change in Body composition

  9 weeks

Other Outcomes (3)

• Change in physical functioning

  9 weeks

• Change in Psychological measures

  9 weeks

• Change in immune profiles and function

  9 weeks

Study Arms (2)

Partly supervised, prescribed exercise group

EXPERIMENTAL

The partly-supervised, prescribed exercise group will be required to undertake two supervised exercise sessions and one unsupervised exercise session at home or in your local area each week. Supervised sessions will consist of exercising on both a treadmill and a stationary exercise bike. The intervention will be progressive, increasing in intensity and duration.

Behavioral: Exercise intervention

Technology enabled, remotely delivered exercise group

EXPERIMENTAL

The technology enabled, remotely delivered exercise group will receive information and advice about exercise that could be undertaken at home or in their local area. In addition, participants will received a Polar A370 fitness tracker wristwatch with heart rate monitoring chest strap. Participants will take part in exercise each week (most likely walking) which will increase in duration over 8-weeks from 105 minutes each week to 150 minutes each week. Each week a member of the research team will have a telephone call with the participant to discuss the exercise prescription.

Behavioral: Polar A380 wristwatch physical activity tracker

Interventions

Exercise intervention BEHAVIORAL

Exercise training will progress incrementally, increasing the duration of exercise on the treadmill by 5 minutes every 2 weeks whereby the final duration on the treadmill will be 35 minutes and the total duration will map onto recommended guidelines of 150 minutes per week. Throughout the 8-weeks, the duration of exercise on the cycle ergometer will remain at 15 minutes. Exercise intensity will progress throughout the 8-week intervention on both the treadmill and the cycle ergometer by 5% every 2 weeks, whereby exercise during the final week will be at 70% VO2max.

Partly supervised, prescribed exercise group

Polar A380 wristwatch physical activity tracker BEHAVIORAL

The research team will monitor individual exercise training weekly using virtual/electronic methods and a 30 minute telephone call. The researcher will provide feedback about how the participant's activity compares to physical activity recommendations, and encouragement and support will be provided verbally.

Technology enabled, remotely delivered exercise group

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-69 years
• History of previous stage I-III invasive breast cancer
• No history of metastatic cancer
• No significant cardiac co-morbidity
• No diagnosis of bilateral breast cancer
• \> 2 months from surgery, chemotherapy and radiotherapy treatments, however patients continuing with endocrine therapy will be included.
• BMI 20 \> \<35 kg.m2
• Oncologist clearance
• Pass physical activity readiness questionnaire (PAR-Q)
• Last menstrual period \>1 year ago

You may not qualify if:

• Current malignancy
• Previous superficial basal cell carcinoma of the skin or prior carcinoma-in situ (including ductal carcinoma in situ/lobular carcinoma in situ of breast) is allowed
• Cardiovascular Disease
• Severe hypertension (\>200/120 mmHg)
• + years since last treatment
• Active infection at recruitment
• Undertaking regular, structured, exercise training defined as self-reported structured physical activity lasting \> 30 minutes on two or more occasions per week (measured before the first visit using the international physical activity questionnaire (IPAQ))
• Contraindication to undertaking an exercise programme including previously diagnosed significant osteoporosis or other co-morbidities at the oncologist's discretion

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr James Turner

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: April 19, 2024
• Study Start: September 5, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)