Breast Cancer FemaleNCT06376578
Exercise Interventions for Improving Health in Breast Cancer Survivors
A study testing Exercise intervention and Polar A380 wristwatch physical activity tracker in people with Breast Cancer Female, run by University of Bath at 1 site in United Kingdom.
Trial summary
Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. Read more about this study
- Who is it for?
- Ages 35 to 69 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Exercise intervention and Polar A380 wristwatch physical activity tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- BMI 20 > <35 kg.m2
- Oncologist clearance
- Pass physical activity readiness questionnaire (PAR-Q)
- Last menstrual period >1 year ago
Who cannot join
- 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)
- 5+ 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing a Technology-enabled, Remotely Delivered Exercise Intervention to Partly-supervised Structured Exercise in Breast Cancer Survivors: a Randomised and Controlled Non- Inferiority Trial
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.
Read the detailed description
Intervention groups:
Remotely-supported exercise group:
The remotely-supported group will received a target for a total duration of exercise each week (outdoor walking) progressing in duration from 105 to 150-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. Participants will be advised how they can break down their target into manageable bouts (e.g., 3 × 35 min walks = 105-min in week 1) and will be instructed to accumulate exercise with a minimum bout-length of 10-min. Intensity will be checked by participants using heart-rate thresholds that corresponded to their V̇O2max. Participants will take part in a weekly 30-min telephone calls to discuss the exercise they have completed, as documented by an internet-based data visualisation platform with data input from a wrist worn fitness tracker that records accelerometry data and heart rate
Partly-supervised exercise group:
The partly-supervised exercise group will undertake 2 supervised (laboratory-based treadmill and cycle ergometer exercise) and 1 unsupervised session per week (e.g., outdoor walking) progressing from 35 to 50-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. During supervised laboratory sessions, intensity will be confirmed and adjusted using indirect calorimetry. The intensity of unsupervised exercise sessions will be recorded using a chest-worn heart rate monitor.
Participant characterisation:
Participants will attend a laboratory for characterisation before and after the intervention (within 7 days) following a 10 hour overnight fast and after refraining from exercise, alcohol, and caffeine in the prior 24 hours. Body mass and height will be measured with the participant wearing light clothing. Body composition monitor. Dual-energy X-ray absorptiometry will be used to quantify fat mass, lean mass, and bone mineral density parameters. Blood pressure will be measured using an automated sphygmomanometer following 15 minutes rest in the supine position.
Physical function will be assessed using three tests. First, the 6-minute walk test, whereby participants will walk as far as possible in 6-minutes between two cones placed 7 meters apart. Second, the sit to stand test, whereby participants will perform as many sit-to-stands as possible in 30 seconds (i.e., seated on a standardised chair, rising to reach full knee extension, returning to a seated position, arms folded across the chest). Third, the 8 foot up timed up and go test, whereby participants will rise from being in a seated position on a standardised chair, walk 8 feet, and return to a seated position as quickly as possible.
Cardiorespiratory fitness will be assessed using a treadmill-based maximal walking exercise test to exhaustion comprising 3-minute stages, beginning at 2.7 kph with a 1% gradient and increasing by 1.3 kph until 6.6 kph, with further intensity increments via increasing gradient by 2%. During the final minute of each stage, heart rate will be measured using telemetry and rating of perceived exertion will be recorded. Expired air samples will be collected using Douglas bags during the final minute of each stage. Oxygen and carbon dioxide within each bag will be analysed using a gas analyser and volume and temperature of the air will be assessed using a digital thermometer and dry gas meter.
- Conditions
- Breast Cancer Female
- Being tested
- Exercise intervention, Polar A380 wristwatch physical activity tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
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.
Polar A380 wristwatch physical activity trackerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Polar A380 wristwatch physical activity tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2max (maximum oxygen uptake)
Measure of cardiorespiratory fitness
Measured: 9 weeks
Secondary outcomes (1)
Change in Body composition
Measured by Body Mass Index and Dual energy x-ray absorptiometry
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start5 Sep 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Turner, Ph.D., FHEA, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376578
- Sponsor's protocol ID
- 245256
- Status last verified
- Apr 2024
- First submitted
- 20 Nov 2020
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Struszczak L, Walhin JP, Betts J, Thompson D, Beresford M, Turner JE. Cardiorespiratory Fitness, Functional Fitness and Body Composition Among Breast Cancer Survivors With 8 Weeks of Exercise Training: A Randomised, Controlled Non-Inferiority Trial Comparing Remotely-Supported and Partly-Supervised Interventions. Cancer Med. 2026 Feb;15(2):e71608. doi: 10.1002/cam4.71608.
PubMed 41656158
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Technology-enabled, Remotely Delivered Exercise Intervention to Partly-supervised Structured Exercise in Breast Cancer Survivors: a Randomised and Controlled Non- Inferiority Trial
- ClinicalTrials.gov ID
- NCT06376578
- Acronym / sponsor ID
- 245256
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intervention groups:
Remotely-supported exercise group:
The remotely-supported group will received a target for a total duration of exercise each week (outdoor walking) progressing in duration from 105 to 150-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. Participants will be advised how they can break down their target into manageable bouts (e.g., 3 × 35 min walks = 105-min in week 1) and will be instructed to accumulate exercise with a minimum bout-length of 10-min. Intensity will be checked by participants using heart-rate thresholds that corresponded to their V̇O2max. Participants will take part in a weekly 30-min telephone calls to discuss the exercise they have completed, as documented by an internet-based data visualisation platform with data input from a wrist worn fitness tracker that records accelerometry data and heart rate
Partly-supervised exercise group:
The partly-supervised exercise group will undertake 2 supervised (laboratory-based treadmill and cycle ergometer exercise) and 1 unsupervised session per week (e.g., outdoor walking) progressing from 35 to 50-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. During supervised laboratory sessions, intensity will be confirmed and adjusted using indirect calorimetry. The intensity of unsupervised exercise sessions will be recorded using a chest-worn heart rate monitor.
Participant characterisation:
Participants will attend a laboratory for characterisation before and after the intervention (within 7 days) following a 10 hour overnight fast and after refraining from exercise, alcohol, and caffeine in the prior 24 hours. Body mass and height will be measured with the participant wearing light clothing. Body composition monitor. Dual-energy X-ray absorptiometry will be used to quantify fat mass, lean mass, and bone mineral density parameters. Blood pressure will be measured using an automated sphygmomanometer following 15 minutes rest in the supine position.
Physical function will be assessed using three tests. First, the 6-minute walk test, whereby participants will walk as far as possible in 6-minutes between two cones placed 7 meters apart. Second, the sit to stand test, whereby participants will perform as many sit-to-stands as possible in 30 seconds (i.e., seated on a standardised chair, rising to reach full knee extension, returning to a seated position, arms folded across the chest). Third, the 8 foot up timed up and go test, whereby participants will rise from being in a seated position on a standardised chair, walk 8 feet, and return to a seated position as quickly as possible.
Cardiorespiratory fitness will be assessed using a treadmill-based maximal walking exercise test to exhaustion comprising 3-minute stages, beginning at 2.7 kph with a 1% gradient and increasing by 1.3 kph until 6.6 kph, with further intensity increments via increasing gradient by 2%. During the final minute of each stage, heart rate will be measured using telemetry and rating of perceived exertion will be recorded. Expired air samples will be collected using Douglas bags during the final minute of each stage. Oxygen and carbon dioxide within each bag will be analysed using a gas analyser and volume and temperature of the air will be assessed using a digital thermometer and dry gas meter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partly supervised, prescribed exercise group | Experimental | Behavioral: Exercise interventionThe 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. |
| Technology enabled, remotely delivered exercise group | Experimental | Behavioral: Polar A380 wristwatch physical activity trackerThe 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. |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
- 5+ years since last treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionExercise 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. | Behavioural | Partly supervised, prescribed exercise group |
| Polar A380 wristwatch physical activity trackerThe 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. | Behavioural | Technology enabled, remotely delivered exercise group |
Primary outcome
Change in VO2max (maximum oxygen uptake)
Time frame: 9 weeks
Measure of cardiorespiratory fitness
1 secondary outcome
Change in Body composition
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 41656158Struszczak L, Walhin JP, Betts J, Thompson D, Beresford M, Turner JE. Cardiorespiratory Fitness, Functional Fitness and Body Composition Among Breast Cancer Survivors With 8 Weeks of Exercise Training: A Randomised, Controlled Non-Inferiority Trial Comparing Remotely-Supported and Partly-Supervised Interventions. Cancer Med. 2026 Feb;15(2):e71608. doi: 10.1002/cam4.71608.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention and Polar A380 wristwatch physical activity tracker in people with Breast Cancer Female, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2max (maximum oxygen uptake) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.