Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376578
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2020-11-20
Brief Title:
Exercise Interventions for Improving Health in Breast Cancer Survivors
Sponsor:
University of Bath
Organization:
University of Bath
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 VO2max 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 eg 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 VO2max 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 eg outdoor walking progressing from 35 to 50-min and 55 to 70 of VO2max 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 ie 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 27 kph with a 1 gradient and increasing by 13 kph until 66 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
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 VO2max 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 eg 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 VO2max 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 eg outdoor walking progressing from 35 to 50-min and 55 to 70 of VO2max 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 ie 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 27 kph with a 1 gradient and increasing by 13 kph until 66 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None