Sedentary LifestyleNCT03212859
Coach2Move: Sustainable in Daily Practice
A study testing Coach2Move in people with Sedentary Lifestyle and Physical Activity, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sedentary Lifestyle, Physical Activity, Frail Elderly Syndrome
- What is being tested?
- Coach2Move
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Nov 2017to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are not ambulatory after treatment and/or are in palliative phase.
- Patients who are indicated to become institutionalised in the near future.
Trial locations and contacts
1 site in 1 country.
About this study
Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults.
Read the 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:
- 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.
- 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.
The objective of this study is to assess the cost-effectiveness of the implementation of a patient and context focused tailored coaching intervention (Coach2Move) in the daily physiotherapy practice for older adults with mobility problems compared to usual physiotherapy. The hypothesis is that Coach2Move leads to better physical outcomes and lower costs than usual care.
- Being tested
- Coach2Move, Usual Care
- Keywords
- older adults, physiotherapy, physical activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach2MoveBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coach2Move Intervention Group | Experimental | Coach2Move Intervention Group Receives: Behavioral: Coach2Move |
| Usual Care | Active comparator | Usual care physiotherapy among older adults Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 27 months
Functional Mobility
The key secondary outcome is functional mobility as measured by the Timed Up and Go test.
Measured: 27 months
Secondary outcomes (4)
Functional Status
The Patient Specific Complaints Scale is used to measure the functional status of a patient. The patients select 3-5 most important mobility problems in daily life and are the most important goals to improve. The degree of hinder is scored by the patient on a 10-point numeric scale.
Measured: 12 months
Cost effectiveness
The direct costs of regular physiotherapy and Coach2Move will be determined on a per patient basis. On patient level, volumes of care will be measured prospectively using medical records and cost questionnaires.
Next will be determining the cost prices for each volume of consumption in order to use these for the volumes registered for each participating patient.
Both outcome measures will be aggregated to one reported value (cost per volume x volumes used). A comparison in costs will be made between the Coach2Move and usual care groups.
Measured: 27 months
Patient Satisfaction
The Global Perceived Satisfaction and Effect score is used to measure the patients' satisfaction about the intervention and the perceived effect on a 7-point Likert scale ranging from very unsatisfied to very much satisfied and very much deterioration to very much improvement, respectively.
Measured: 27 months
Level of Frailty
To measure the level of frailty and participation, the Evaluative Frailty Index is used. This questionnaire consists of 50 items on deficits in health (symptoms, signs and disabilities) in multiple domains (physical, psychological, social and general health status).
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start6 Nov 2017
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- stepped wedge cluster randomised trial and mixed methods process analysis
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Ward Heij, MSc, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212859
- Sponsor's protocol ID
- 104612
- Status last verified
- Mar 2021
- First submitted
- 28 Jun 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36200397Heij 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.
PubMed 31846501
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coach2Move: Sustainable in Daily Practice
- ClinicalTrials.gov ID
- NCT03212859
- Acronym / sponsor ID
- 104612
- Keywords
- older adults, physiotherapy, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
The objective of this study is to assess the cost-effectiveness of the implementation of a patient and context focused tailored coaching intervention (Coach2Move) in the daily physiotherapy practice for older adults with mobility problems compared to usual physiotherapy. The hypothesis is that Coach2Move leads to better physical outcomes and lower costs than usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- stepped wedge cluster randomised trial and mixed methods process analysis
| Arm | Type | Receives |
|---|---|---|
| Coach2Move Intervention Group | Experimental | Behavioral: Coach2MoveCoach2Move Intervention Group |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care physiotherapy among older adults |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are not ambulatory after treatment and/or are in palliative phase.
- Patients who are indicated to become institutionalised in the near future.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach2MoveCoach2Move 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. | Behavioural | Coach2Move Intervention Group |
| Usual CareUsual 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. | Behavioural | Usual Care |
Primary outcome
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.
4 secondary outcomes
Functional Status
Time frame: 12 months
Cost effectiveness
Time frame: 27 months
Patient Satisfaction
Time frame: 27 months
Level of Frailty
Time frame: 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 36200397Heij 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.
- Derived from this study: PubMed 31846501Heij 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.
- Previous TrialLink provided by the sponsor.
- Previous TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ward Heij, MSc principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach2Move in people with Sedentary Lifestyle and Physical Activity, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Physical Activity (time frame: 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212859, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.