NCT06894914

Brief Summary

Physically frail older adults often have chronic conditions that contribute to a higher chance of them being limited in daily activities and becoming dependent. Physical activity can help to better manage chronic conditions and prevent frailty. In this project, the counselling approach using the new Canadian 24-hour Movement Guidelines will be adapted for older adults at an early state of frailty. This new approach will be tested against the one in current use by physiotherapists. This ethics application will address the pilot implementation evaluation, including interviews and focus groups, conducted to refine the new approach.

Trial Health

77
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
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress14%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

February 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 23, 2025

Last Update Submit

February 17, 2026

Conditions

Keywords

PhysiotherapyPhysical activitySleepCounselling

Outcome Measures

Primary Outcomes (1)

  • Patient's daily time in moderate/vigorous physical activity (minutes/day)

    Minutes spent in moderate/vigorous physical activity per day

    6 months

Secondary Outcomes (19)

  • Patient's daily time in moderate/vigorous physical activity (minutes/day)

    12 months

  • Patient's daily time in light physical activity (minutes/day)

    6 months

  • Patient's daily time in light physical activity (minutes/day)

    12 months

  • Patient's daily time in sedentary behaviour (minutes/day)

    6 months

  • Patient's daily time in sedentary behaviour (minutes/day)

    12 months

  • +14 more secondary outcomes

Study Arms (2)

24-hour Activity Counselling

EXPERIMENTAL

Participating physiotherapists will be trained to deliver counselling that focuses on increasing moderate-to-vigorous physical activity, with a balance of activity, rest and sleep in a 24-hour day. Patients (n=4) of these physiotherapists will receive the 24-hour Activitiy Counselling

Behavioral: 24-hour Activity Counselling

Current Physical Activity Counselling

ACTIVE COMPARATOR

Participating physiotherapists will continue delivering counselling that focuses on achieving 150 minutes/week of moderate-to-vigorous physical activity, which is the current practice. Patients (n=4) of these physiotherapists will receive the Current Physical Activitiy Counselling

Behavioral: 24-hour Activity Counselling

Interventions

Physiotherapists will participate in the self-paced brief action planning (BAP) online training (2-4 hours long), followed by 2-3 hours of practice and feedback over the phone with an experienced BAP instructor. In addition, they will attend a 2-hour session with the research team on training around on prescribing physical activity while balancing with rest and sleep. Once training is complete the PT can start implementing the counselling approach with the older adult patients.

24-hour Activity CounsellingCurrent Physical Activity Counselling

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible PTs are those who self-report at least 40% of their caseload is working with older adults and practice in the in the Greater Vancouver Area. In addition, they are willing to:
  • participate in online training for the assigned physical activity counselling strategy
  • be randomised to one of the counselling groups.

You may not qualify if:

  • Older adults:
  • are age \> 65 years
  • live in the community
  • have 1 or 2 of the deficits in the CHS index
  • have \> 1 chronic conditions
  • are able to walk 3 metres with or without an assistive device
  • have a Mini-Mental State Examination score \> 24/30
  • do not have a diagnosed psychiatric condition (e.g., depression)
  • understand, speak and read English proficiently
  • are willing to have their physiotherapy sessions audio-recorded
  • are able to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

RECRUITING

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Linda Li, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 25, 2025

Study Start

January 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The investigators plan to share individual participant data from this clinical trial, including demographics, baseline characteristics, primary outcome measures, and key secondary outcomes, with qualified researchers upon request after the study results have been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
TBA
Access Criteria
Data will be provided in a de-identified format through a secure online repository, and access will require submission of a research proposal outlining the intended analysis and relevant ethics approvals.

Locations