NCT04318574

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

April 6, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

March 17, 2020

Last Update Submit

March 19, 2020

Conditions

Keywords

CancerBalance impairmentSelf-efficacyFear of fallingBalance training

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

Secondary Outcomes (4)

  • Self-report ABC Scale

    1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

  • Self-report MFES

    1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

  • self-report Fear of Falling

    1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

  • Self-report Quality of Life FACT-G

    1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

Study Arms (1)

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

Other: Balance, Agility, Strengthening Exercise (BASE) Class

Interventions

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.

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

AlkaliesArtifacts

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsInvestigative Techniques

Central Study Contacts

Karen Dobbin, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Instructor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 24, 2020

Study Start

April 6, 2020

Primary Completion

June 30, 2022

Study Completion

January 1, 2023

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share