A Prospective Study of Video-assisted Exercise Program for the Breast Cancer Survivors

ConditionMastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego

About this trial

The investigators cancer rehabilitation/recovery program, Strong Survivor, has been designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric and cancer survivor populations. Strong Survivor is 16-week iterative curricular program with three core components: aerobic fitness, balance and mobility, and muscular strength and power. Classes will be held twice per week. The first 4 classes will be deployed in a small class of up to 5 people (first 2 weeks), then one class per week with the small class and one class per week is with a larger class of up to 15 people (weeks 3 and 4). The program is then continued for 12 additional weeks in a larger class using principles and exercises specifically trained during the small group classes.

All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.

Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger).

Additionally, participants' will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space.

All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persons, aged 18+

Undergone breast cancer surgery within the 4 weeks of being contacted for pre-screening

Own a computer or alternative device capable of real-time Zoom videoconferencing, including access to internet or cellular connectivity sufficient in broadband. This requires a screen of at least 7 inches (a cell phone is large enough for us to see the participant, but not for the participant to see us).

Provision of signed and dated informed consent form

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 16 weeks remotely exercise program

    Other intervention

    16 weeks, twice per week, remotely exercise program

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Strong SurvivorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Attendance

The number of sessions each participant attended (out of the total number of sessions offered) will be recorded and used to evaluate engagement in the tele-video real time exercise program in a geriatric breast cancer patient population. A participant is considered to have completed the study if he or she has completed all phases of the study including responding to follow up queries regarding falls for up to 1 year following the final measurement visit. Acceptability is based on attendance.

Time frame
16 weeks

Secondary outcomes

1

Cardiorespiratory Fitness: Time taken to reach 85% of age predicted heart rate max

The time taken to reach 85% of age predicted heart rate max , from a submaximal exercise testing on a treadmill, will be used to evaluate Cardiorespiratory Fitness; pre and post program times will be compared for each study participant.

Time frame
Before the beginning and at the end of the 16 weeks program
2

Strength and Balance

Short Physical Performance Battery test (4-part validated scale for fall risk) will be used to evaluate Strength and Balance

Time frame
Before the beginning and at the end of the 16 weeks program
3

Fall Risk assessment

The Timed Up and Go, Standardized assessment of functional mobility, will be used for Fall Risk assessment

Time frame
Before the beginning and at the end of the 16 weeks program
4

Balance

The Better Balance Testing, measure of proprioceptive and vestibular function utilizing computerized dynamic posturography, will be use to measure balance

Time frame
Before the beginning and at the end of the 16 weeks program

Other outcomes

Sponsors and contacts

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