Clinical trial NCT04318574: The Effects of a 6-week Balance, Agility, Strengthening Exercise Class
Official title: The Effects of a 6-week Balance, Agility, Strengthening Exercise (BASE) Class on Balance Performance, Self-Efficacy, and Fear of Falling in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Keywords: Cancer
Balance impairment
Self-efficacy
Fear of falling
Balance training
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cancer treatments can have a significant impact on a cancer survivor's function and independence, and these patients can have twice the incidence of falls than their cancer-free peers. Balance programs of varying lengths have shown to improve balance performance, increase self-efficacy and decrease fear of falling; however, there are limited intervention studies amongst cancer survivors, and none that examine the combination of balance performance, self-efficacy and fear of falling. It is believed that this study will show that a 6-week Balance, Agility, Strengthening Exercise (BASE) Class is a sufficient time frame to demonstrate a positive effect on balance performance, self-efficacy, and fear of failing in cancer survivors, and will add to the body of knowledge in this population.

Detailed description: Objectives Given that this combination of outcomes have not been sufficiently measured in the cancer population, and most balance and agility training programs are 12 weeks or more in length, the objectives of this study is to determine the effects of a 6-week intervention, the Balance, Agility, Strengthening Exercise (BASE) Class, on the balance performance, self-efficacy, and the fear of falling in cancer survivors.

Methods This study is a 3 year exercise interventional study, with 20 participants per year. In year one of the study, 20 participants will be enrolled in a 6-week Balance, Agility, Strengthening Exercise (BASE) Class. The pre-program data collection will include: demographic data; initial intake examination utilizing standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life. The participants will attend the BASE class twice weekly for 6-weeks. The post-program data collection is to include the same outcome measures.

Subsequent years will be an observational study of the same design, enrolling 20 participants in year 2 and 3 for a 6-week BASE class. A total of 60 participants will be recruited over 3 years providing adequate power to assess program efficacy. Based on the resources available, this study can only accommodate 20 participants per year and can only be conducted for a 6-week period each year of the study.

Participants and recruitment Posters and hand bills will be distributed and placed throughout CancerCare recruiting participants for the study (self-referral). In addition, hand bills will provided for oncologists, oncology nurses, and psychosocial clinicians to give to patients/potential participants within the clinical areas at CancerCare. After receiving the hand bill with the study description and information, potential participants can choose to phone or e-mail the PI to indicate their interest in the study. A phone interaction will take place between the PI and potential participant to determine if they meet the inclusion criteria. Once it is determined that they meet the inclusion criteria, an in-person meeting will be arranged and they will be provided with the study's objectives, risks and benefits, and the consent document. Time will be allowed for the potential participant to ask questions and to consider their enrollment in the study. After a thorough discussion and review of the documents, the potential participant will be asked to sign the consent form. If requested, a person will be allowed to take the consent form home for further consideration prior to signing.

Data collection Prior to the start of the BASE Class, an initial assessment will take place. This assessment will utilize standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life.

Intervention:

The BASE class will run twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

Statistical Analysis Pre-post paired comparisons will be conducted for each balance performance and self-reported questionnaire measure. A paired T-test or Wilcoxon signed ranks test will be performed according to the observed distributions.

Eligibility criteria: Inclusion Criteria:

* community-dwelling
* ambulatory
* diagnosed with hematological or solid cancer tumors (except brain tumors/brain metastases)
* age \>18 years
* self-identified as experiencing impaired balance, and scoring less than 80% on the Activities-specific Balance Confidence Scale
* able to communicate in English

Exclusion Criteria:

* metastatic cancer
* those unable to provide informed consent
* those having previously received physiotherapy and exercise instruction from the principal investigator.

Primary outcomes:
measure: Balance Performance - miniBest
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Balance Performane - TUG
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Balance Performance - Timed Unipedal Stance Test
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Balance Performance - 6-meter Gait Speed Test
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Balance Performance - Four Square Step Test
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Secondary outcomes:
measure: Self-report ABC Scale
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Self-report MFES
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: self-report Fear of Falling
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
measure: Self-report Quality of Life FACT-G
timeFrame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Other outcomes:
Locations:
Study officials:
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