NeoplasmsNCT04318574
The Effects of a 6-week Balance, Agility, Strengthening Exercise Class
A study testing Balance, Agility, Strengthening Exercise (BASE) Class in people with Neoplasms, run by University of Manitoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Balance, Agility, Strengthening Exercise (BASE) Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2020to 1 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- metastatic cancer
- those unable to provide informed consent
- those having previously received physiotherapy and exercise instruction from the principal investigator.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Balance, Agility, Strengthening Exercise (BASE) Class
- Keywords
- Cancer, Balance impairment, Self-efficacy, Fear of falling, Balance training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance, Agility, Strengthening Exercise (BASE) ClassOther
The BASE class will be conducted 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Balance, Agility, Strengthening Exercise (BASE) class intervention - a 6-week exercise class to determine the change in balance performance, fear of falling and self-efficacy Receives: Other: Balance, Agility, Strengthening Exercise (BASE) Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance - miniBest
Mini-Balance Evaluation Systems Test is a 14-item balance scale covering a broad spectrum of performance tasks including dynamic body stability, transfers, gait, variation of support surfaces, and of visual conditions, obstacle negotiation, reactions to external forces and performance during dual-tasking.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performane - TUG
Timed Up and Go: a rise from a chair, 3-meter walk, turn and walk back to chair and sitting. Designed to measure mobility, balance, and locomotor performance; evaluates falls risk and basic functional mobility.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Timed Unipedal Stance Test
A simple test for measuring static aspects of balance ability, measured in seconds with eyes open and eyes closed; useful when combined with other balance performance tests.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - 6-meter Gait Speed Test
A 6-meter walking test measured in meters/second; an indicator of walking ability, function, and mobility.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Four Square Step Test
A timed measurement of stepping whilst changing direction to provide a measure of dynamic standing balance and mobility; stepping forwards, sideways, and backwards over obstacles in a specified sequence.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Secondary outcomes (4)
Self-report ABC Scale
Activities-specific Balance Confidence Scale is a 16-item self-report questionnaire examining a person's confidence in a broad range of activities with various difficulties; to assess balance confidence in ambulatory community-dwelling older adults
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report MFES
Modified Fall Efficacy Scale International is a 15 question self-rated scale assessing a person's confidence in performing activities in the home, plus additional items related to outdoor activities.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
self-report Fear of Falling
A 14 item scale that examines fear of falling and the effect it has on participation in various activities
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report Quality of Life FACT-G
Functional Assessment of Cancer Therapy - General is a 27-item self-report instrument that consists of 4 sub-scales: physical well-being, social well-being, emotional well-being, and functional well-being to measure quality of life for cancer patients.
Measured: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start6 Apr 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Dobbin, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318574
- Sponsor's protocol ID
- H2019:470
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04318574
- Acronym / sponsor ID
- H2019:470
- Conditions
- Neoplasms
- Keywords
- Cancer, Balance impairment, Self-efficacy, Fear of falling, Balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 6 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 24 Mar 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Balance, Agility, Strengthening Exercise (BASE) ClassBalance, Agility, Strengthening Exercise (BASE) class intervention - a 6-week exercise class to determine the change in balance performance, fear of falling and self-efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- metastatic cancer
- those unable to provide informed consent
- those having previously received physiotherapy and exercise instruction from the principal investigator.
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 |
|---|---|---|
| Balance, Agility, Strengthening Exercise (BASE) ClassThe BASE class will be conducted 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. | Other | Interventional |
Primary outcome
Balance Performance - miniBest
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Mini-Balance Evaluation Systems Test is a 14-item balance scale covering a broad spectrum of performance tasks including dynamic body stability, transfers, gait, variation of support surfaces, and of visual conditions, obstacle negotiation, reactions to external forces and performance during dual-tasking.
Balance Performane - TUG
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Timed Up and Go: a rise from a chair, 3-meter walk, turn and walk back to chair and sitting. Designed to measure mobility, balance, and locomotor performance; evaluates falls risk and basic functional mobility.
Balance Performance - Timed Unipedal Stance Test
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A simple test for measuring static aspects of balance ability, measured in seconds with eyes open and eyes closed; useful when combined with other balance performance tests.
Balance Performance - 6-meter Gait Speed Test
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A 6-meter walking test measured in meters/second; an indicator of walking ability, function, and mobility.
Balance Performance - Four Square Step Test
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A timed measurement of stepping whilst changing direction to provide a measure of dynamic standing balance and mobility; stepping forwards, sideways, and backwards over obstacles in a specified sequence.
4 secondary outcomes
Self-report ABC Scale
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report MFES
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
self-report Fear of Falling
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report Quality of Life FACT-G
Time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Balance, Agility, Strengthening Exercise (BASE) Class in people with Neoplasms, run by University of Manitoba.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Dobbin, MSc (12042289361, kdobbin@cancercare.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Performance - miniBest (time frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2020.