NCT03212859

Brief Summary

Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

June 28, 2017

Last Update Submit

March 16, 2021

Conditions

Keywords

older adultsphysiotherapyphysical activity

Outcome Measures

Primary Outcomes (2)

  • Self-reported Physical Activity

    The primary outcome of the study is physical activity measured by the LAPAQ questionnaire, subscale moderate activity. This subscale of the LAPAQ is a comprehensive questionnaire on diverse (physical) activities of daily living with moderate intensity including walking, riding a bicycle etc. and is specifically designed to assess habitual physical activity of the elderly.

    27 months

  • Functional Mobility

    The key secondary outcome is functional mobility as measured by the Timed Up and Go test.

    27 months

Secondary Outcomes (4)

  • Functional Status

    12 months

  • Cost effectiveness

    27 months

  • Patient Satisfaction

    27 months

  • Level of Frailty

    27 months

Other Outcomes (2)

  • Implementability

    27 months

  • Budget Impact

    27 months

Study Arms (2)

Coach2Move Intervention Group

EXPERIMENTAL

Coach2Move Intervention Group

Behavioral: Coach2Move

Usual Care

ACTIVE COMPARATOR

Usual care physiotherapy among older adults

Behavioral: Usual Care

Interventions

Coach2MoveBEHAVIORAL

Coach2Move is a multicomponent physiotherapeutic approach in addition to usual care physiotherapy consisting of: * Extensive intake during which not only impairments and disabilities, but wishes, barriers and facilitators considering physical functioning are profoundly examined. * Motivational interviewing is used to find and deal with barriers for becoming physically active and shared-decision making in goal setting. * The approach is patient focused (tailor made) and goal-oriented: the physiotherapist coaches the patient and the environment in reaching and maintaining their own goals. * In consultation with the patient, a stratified intervention is chosen by picking the best fitting option out of three patient-tailored intervention profiles with a predefined number of intervention sessions.

Coach2Move Intervention Group
Usual CareBEHAVIORAL

Usual care physiotherapy among older adults: * Intake of 30 minutes consisting of examining medical history, physical functioning and functional exercises to assess the demand for care. * Use of treatment modalities to enhance physical functioning (strength, mobility, coordination, balance etc.) * Consultation and advisory role in relation to the functional status of geriatric patients and his/her relations. * Collaborate with other disciplines in a multidisciplinary context.

Usual Care

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 70 years or older
  • Community-dwelling
  • mobility related problems or problems related to activities of daily living
  • sedentary lifestyle or are at risk of losing an active lifestyle

You may not qualify if:

  • Patients who are not ambulatory after treatment and/or are in palliative phase.
  • Patients who are indicated to become institutionalised in the near future.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ward Heij

Nijmegen, Gelderland, 6500 HB, PO. 9101, Netherlands

Location

Related Publications (2)

  • Heij W, Sweerts L, Staal JB, Teerenstra S, Adang E, van der Wees PJ, Nijhuis-van der Sanden MWG, Hoogeboom TJ. Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial. Phys Ther. 2022 Dec 6;102(12):pzac138. doi: 10.1093/ptj/pzac138.

  • Heij W, Teerenstra S, Sweerts L, Staal JB, Nijhuis-van der Sanden MWG, Hoogeboom TJ. Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial. Phys Ther. 2020 Apr 17;100(4):653-661. doi: 10.1093/ptj/pzz183.

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ward Heij, MSc

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: stepped wedge cluster randomised trial and mixed methods process analysis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 11, 2017

Study Start

November 6, 2017

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations