Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of a 6-week Balance, Agility, Strengthening Exercise Class

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318574
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Dobbin, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Neoplasms Other: Balance, Agility, Strengthening Exercise (BASE) Class Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 6, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional
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
Other: Balance, Agility, Strengthening Exercise (BASE) Class
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Self-report ABC Scale [ Time Frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class ]
    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

  2. Self-report MFES [ Time Frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class ]
    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.

  3. self-report Fear of Falling [ Time Frame: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class ]
    A 14 item scale that examines fear of falling and the effect it has on participation in various activities

  4. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318574


Contacts
Layout table for location contacts
Contact: Karen Dobbin, MSc 12042289361 kdobbin@cancercare.mb.ca

Sponsors and Collaborators
University of Manitoba
Layout table for additonal information
Responsible Party: Karen Dobbin, Principal Investigator, Clinical Instructor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04318574    
Other Study ID Numbers: H2019:470
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Dobbin, University of Manitoba:
Cancer
Balance impairment
Self-efficacy
Fear of falling
Balance training