NCT04494711

Brief Summary

With the aging population, the prevalence of chronic conditions continues to rise, affecting 1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence, physical competence and knowledge, to take responsibility for engagement in physical activity for life", has emerged as a promising strategy to increase movement for children. However, little is known about how physical literacy can impact aging adults. A working definition of physical literacy for adults focusing on mobility, function and self-monitoring provides opportunity to guide public health programs in addressing the rehabilitation needs of persons living with multiple chronic conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

July 28, 2020

Last Update Submit

May 9, 2023

Conditions

Keywords

Adultsphysical functionphysical literacy

Outcome Measures

Primary Outcomes (6)

  • Physical Function at Baseline (Week 1)

    The Patient Specific Functional Scale is a patient-reported questionnaire that asks participants to identify up to 5 important activities they are having difficulty with because of their health problem, and to rate their ability to perform those activities on a scale of 0 (unable to perform the activity) to 10 (able to perform the activity like they always have).

    Week 1

  • Change in Physical Function from Week 1

    The Patient Specific Functional Scale is a patient-reported questionnaire that asks participants to identify up to 5 important activities they are having difficulty with because of their health problem, and to rate their ability to perform those activities on a scale of 0 (unable to perform the activity) to 10 (able to perform the activity like they always have).

    Week 5

  • Mobility Survey at Baseline (Week 1)

    Manty Preclinical Disability Scale: Patient report questionnaire has been created from the work by Many (2007). Self reported mobility is determined by asking participants to rate their ability to walk 2.0 km, walk 0.5 km and climb up 1 flight of stairs on a scale of 1 (able to manage without difficulty) to 5 (unable to manage even with help). To identify persons at an early stage of mobility limitation (preclinical mobility limitation), additional questions were posed to participants who reported no task difficulty. The questions concerned the modification of task performance and the alternatives given were resting in the middle of the performance, using an aid, taking support from handrails, having reduced the frequency of performing the task, having slowed down performance of the task, experiencing tiredness when performing the task, or some other change in carrying out the task.

    Week 1

  • Change in Mobility from Week 1

    Manty Preclinical Disability Scale: Patient report questionnaire has been created from the work by Many (2007). Self reported mobility is determined by asking participants to rate their ability to walk 2.0 km, walk 0.5 km and climb up 1 flight of stairs on a scale of 1 (able to manage without difficulty) to 5 (unable to manage even with help). To identify persons at an early stage of mobility limitation (preclinical mobility limitation), additional questions were posed to participants who reported no task difficulty. The questions concerned the modification of task performance and the alternatives given were resting in the middle of the performance, using an aid, taking support from handrails, having reduced the frequency of performing the task, having slowed down performance of the task, experiencing tiredness when performing the task, or some other change in carrying out the task.

    Week 5

  • Self-regulation at Baseline (Week 1)

    The Health education impact questionnaire (heiQ): A Patient report questionnaire that aims to evaluate eight self-management skills in people with chronic conditions. Consists of 35 items across 7 independent constructs: health-directed activity; positive and active engagement in life; emotional wellbeing; self-monitoring and insight; constructive attitudes and approaches; skill and technique acquisition; social integration and support. Each construct comprises an independent questionnaire. Each construct-specific questionnaire includes 4-6 items rated on a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). The sum of scores for all items is divided by the number of items; construct scores range between 1 and 4. A higher score indicates better self-management, with the exception of the emotional wellbeing construct for which a lower score means better emotional well being.

    Week 1

  • Change in Self-regulation from Week 1

    The Health education impact questionnaire (heiQ): A Patient report questionnaire that aims to evaluate eight self-management skills in people with chronic conditions. Consists of 35 items across 7 independent constructs: health-directed activity; positive and active engagement in life; emotional wellbeing; self-monitoring and insight; constructive attitudes and approaches; skill and technique acquisition; social integration and support. Each construct comprises an independent questionnaire. Each construct-specific questionnaire includes 4-6 items rated on a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). The sum of scores for all items is divided by the number of items; construct scores range between 1 and 4. A higher score indicates better self-management, with the exception of the emotional wellbeing construct for which a lower score means better emotional well being.

    Week 5

Secondary Outcomes (7)

  • Physical Activity at Baseline (Week 1)

    Week 1

  • Change in Physical Activity from week 1

    Week 5

  • Self-efficacy to manage chronic conditions at Baseline (Week 1)

    Week 1

  • Change in Self-efficacy from week 1

    Week 5

  • Knowledge and Awareness of health changes that occur with aging Baseline (Week 1)

    Week 1

  • +2 more secondary outcomes

Study Arms (1)

Physical functional literacy

EXPERIMENTAL

5 week physical literacy program for adults with multiple chronic conditions

Behavioral: Physical Functional Literacy for Adults

Interventions

A 5 week physical literacy for program focused on virtual knowledge translation strategies to improve function and mobility for adults with multiple chronic conditions. This is a population -based approach to rehabilitation

Physical functional literacy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed from a physician with 2 or more chronic conditions and have lived with the conditions for ≥1 year
  • Able to speak English
  • Employed full time as a teacher in the Hamilton-Wentworth School Board, Ontario between the ages of 45 and 65 years.
  • Describe themselves as moderately physically active or inactive over the past 12 months

You may not qualify if:

  • Advised by physician not to participate in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celeste Petrusevski

Hamilton, L8S4L8, Canada

Location

MeSH Terms

Conditions

Multiple Chronic ConditionsMobility Limitation

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Julie Richardson, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Mixed Methods
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Assistant Dean School of Rehabilitation Science

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

January 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations