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Clinical Trials/NCT03212859
NCT03212859CompletedNot Applicable

Coach2Move: Sustainable in Daily Practice

Radboud University Medical Center2 sites in 1 country292 target enrollmentStarted: November 6, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
292
Locations
2
Primary Endpoint
Self-reported Physical Activity

Study Overview

Brief Summary

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

Detailed Description

In a previous trial, researchers demonstrated that the Coach2Move approach is superior to regular physiotherapy in terms of increasing physical activity, reducing frailty, improving quality of life and reducing healthcare costs. In short, in less physiotherapeutic sessions, better outcomes were realized.

Despite these promising findings, the research group still has questions regarding the generalisability of these findings. The reservations towards the generalisability of the approach are caused by the following:

  1. A modest (n=130), yet somewhat selective study sample was included: nearly half of the eligible individuals declined randomisation and thereby participation. An understanding is needed how this group of eligible non volunteers respond to Coach2Move. Therefore, a study design that avoids randomisation at the patient level will be used.
  2. The Coach2Move approach significantly increased the level of moderate physical activity among the treatment group and reduced levels of frailty significantly after 6 months, but the clinical importance of these findings is still unclear. Thus, a replication of the effects in the light of physical functioning is needed in a larger more variable study population and with a longer follow-up.

In addition, the results from the earlier carried out RCT concerning the cost-effectiveness of Coach2Move have to be replicated on a larger scale.

For the reasons mentioned above, it is important to further implement Coach2Move and study its effect, costs, and feasibility in current practice. A stepped wedge cluster randomised trial design is chosen because in the opinion of the researchers, the implementation strategy will do more good than harm (making a parallel design, in which certain practices do not receive the intervention or to withdraw the intervention as would occur in a cross-over design, is unethical) and it furthermore minimizes contamination.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Self-reported Physical Activity

Time Frame: 27 months

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.

Functional Mobility

Time Frame: 27 months

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

Secondary Outcomes

  • Functional Status(12 months)
  • Cost effectiveness(27 months)
  • Patient Satisfaction(27 months)
  • Level of Frailty(27 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Coach2Move: Sustainable in Daily Practice | Clinical Trial