SarcopeniaPUMP-fitNCT05672004
Implementation of ProMuscle in Daily Practice
A study testing PUMP-fit strategy (implementation toolbox) and Implementation as usual in people with Sarcopenia and Frailty, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Implementation of a previously shown (cost-)effective combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Aging Problems
- What is being tested?
- PUMP-fit strategy (implementation toolbox) and Implementation as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 1 May 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 65 years or older
- Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude)
- Able to understand Dutch
- Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength
Who cannot join
- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.
Implementation of a previously shown (cost-)effective combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands.
Read the detailed description
ProMuscle is a combined lifestyle intervention that has been shown effective in improving muscle mass, muscle strength, and physical functioning in community-dwelling older adults. Potentially, it could facilitate older people in maintaining their functional independence.
Despite the promising results, ProMuscle is still not part of daily care. Previously factors influencing successful implementation were identified and implementation strategies targeting these factors were developed and formatted as an implementation toolbox for healthcare professionals.
To increase the likelihood of successful implementation of ProMuscle, this study aims to investigate the PUMP-fit strategy (implementation toolbox) effectiveness on the adoption of ProMuscle in community-care
A hybrid type 3 stepped wedge cluster trial with a mixed method analysis will be conducted to assess the effectiveness of the PUMP-fit implementation toolbox. A stepped wedge trail is chosen because of the ability to compare between clusters, but also within clusters.
Moreover, ProMuscle is already found effective, and the researchers hypothesized that the implementation toolbox should be assessable for all healthcare professionals in the 'Foodvalley'. At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect.
In addition, the researchers hypothesized that the program would be adapted to specific contexts' outcomes from the recipients of ProMuscle will be collected. A hybrid type three trial aims to investigate the implementation as a primary outcome and the effect of the (adapted) intervention as a secondary outcome.
- Conditions
- Sarcopenia, Frailty, Aging Problems
- Being tested
- PUMP-fit strategy (implementation toolbox), Implementation as usual
- Keywords
- implementation, lifestyle intervention, prevention
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUMP-fit strategy (implementation toolbox)Other
Healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting (during the control period).
Healthcare professionals will be informed about the platform and toolbox. Healthcare professionals receive a personal log-in for the online platform. Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible on the platform Within the separate environment of the online platform, healthcare professionals can access their implementation toolbox. The toolbox is tailored to their personal context based on the results of the 'Readinesstool'.
Implementation as usualOther
First, healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting.
At the end of the training healthcare professionals are informed about the mandatory conditions to implement ProMuscle (champion, material, approval of management).
Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible. Results contain a graph of possible barriers for implementation in their practice.
Hereafter they will be instructed to start with implementation as usual.
| Study group | Role | What they receive |
|---|---|---|
| Implementation as usual | Active comparator | Healthcare professionals will be instructed to implement ProMuscle in their practice as usual Receives: Other: Implementation as usual |
| PUMP-fit strategy: Implementation toolbox | Experimental | Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation Receives: Other: PUMP-fit strategy (implementation toolbox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of ProMuscle
The number of healthcare professionals delivering ProMuscle is measured with administrative data and the REport of Sustainment Scale (PRESS). Because it is not possible to measure adoption at baseline, The Measure of Innovation-Specific Implementation Intentions (MISII) questionnaire will be used to measure adoptability (the attention to adopt an EBP) at T0
Measured: 36 weeks
Fidelity of ProMuscle
Fidelity is the degree to which an intervention was implemented as prescribed. The number of activities described in the ProMuscle guideline executed by the healthcare professionals will be assessed with a self-report checklist based on the content of the ProMuscle intervention. Comparing the outcomes of fidelity before and after receiving the PUMP-fit strategy can indicate whether the toolbox contributed to the fidelity of delivery of ProMuscle.
Measured: 36 weeks
Secondary outcomes (16)
Fidelity of the PUMP-fit strategy
Fidelity is the degree to which an intervention was implemented as prescribed. For the PUMP-fit strategy, fidelity is defined as the degree to which the activities described in the online implementation toolbox are implemented as prescribed.
The number of implementation activities described in the implementation toolbox and the time healthcare professionals are active in the implementation toolbox will be collected from the online platform (tracking activity).
Fidelity according to healthcare professionals will be assessed with a self-report containing statements based on the Fidelity of Implementation (FOI) framework. The statements are scored with a 5-point Likert scale, the higher the score, the higher the fidelity.
In addition, the experience of healthcare professionals about the fidelity will be investigated during the process evaluation guided by the domain "implementation" of the RE-AIM framework.
Measured: 24 weeks
Acceptability of the PUMP-fit strategy
Acceptability will be measured with the translated Acceptability of Intervention Measure (AIM). The AIM contains four statements about the acceptability of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the acceptability of the PUMP-fit strategy.
Measured: 36 weeks
Appropriateness of the PUMP-fit strategy
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM). The IAM contains four statements about the appropriateness of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the appropriateness of the PUMP-fit strategy.
Measured: 36 weeks
Feasibility of the PUMP-fit strategy
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire. The FIM contains four statements about the feasibility of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the feasibility of the PUMP-fit strategy.
Measured: 36 weeks
Barriers and facilitators for implementation of ProMuscle
Barriers and facilitators will be assessed with a questionnaire developed by the research group. The questionnaire contains statements about different factors that could influence implementation (CFIR framework) and is based on the 'Wandersman readiness thinking tool' and 'Organization Readiness'. Statements are rated on a 5-point Likert scale. Factors that are scored three or lower will be defined as barriers. Factors that are scored with four of higher will be defined as facilitators.
Moreover, during the washout period and process evaluation barriers and facilitators will be identified in interviews with healthcare professionals implementing ProMuscle.
Measured: 36 weeks
Acceptability of ProMuscle
Acceptability of ProMuscle will be measured with the translated Acceptability of Intervention Measure (AIM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale. The higher the score, the higher the score the higher the acceptability of the ProMuscle intervention
Measured: 36 weeks
Appropriateness of ProMuscle
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score the higher the appropriateness of ProMuscle.
Measured: 36 weeks
Feasibility of ProMuscle
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score, the higher the score the higher the feasibility of the ProMuscle intervention
Measured: 36 weeks
Reach of ProMuscle
Reach is defined as the number of older adults and will be measured by administrative data.
Measured: 36 weeks
Sustainment of ProMuscle
Sustainment of the implementation of ProMuscle will be measured with the Program Sustainability Assessment Tool (PSAT) and during a one-hour focus group guided by the RE-AIM framework (domain Maintenance) to assess if ProMuscle became part of daily care.
Measured: 54 weeks
Physical functioning recipients of ProMuscle
The Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.
Measured: 54 weeks
Functional lower extremity strength recipients of ProMuscle
Repeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.
Measured: 54 weeks
Leg strength recipients of ProMuscle
The one repetition (1RM) of leg strength is performed on leg press machines. The 1RM is conducted by participating healthcare professionals.
The 1RM measures the maximal strength and can be used to develop the exercise program.
Measured: 54 weeks
Functional mobility recipients of ProMuscle 1RM
Functional mobility is measured with the Timed-Up-And-Go test (TUG).
Measured: 54 weeks
Care dependency recipients of ProMuscle
Healthcare professionals report the current health status of the recipients in terms of care dependency. Recipients are asked if they receive care. Answers can be categorized as no care, care from spouse or family, domestic worker, home care, nursing or other help.
Measured: 54 weeks
Lean body mass recipients ProMuscle
Lean body mass is measured with the bioelectrical impedance analysis (BIA)
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- stepped wedge cluster trial and mixed methods process analysis
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Regiodeal Foodvalley
- Responsible party
- Principal investigator, Patricia van der Laag, UMC Utrecht
- Investigators
- Lisette Schoonhoven, prof, Principal investigator, Julius Center, University Medical Center Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672004
- Sponsor's protocol ID
- 22/050
- Acronym
- PUMP-fit
- Status last verified
- May 2024
- First submitted
- 19 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Laag PJ, Dorhout BG, Bos LR, Veenhof C, Barten DJ, Schoonhoven L. Exploring working mechanism of an implementation strategy bundle on the implementation of a lifestyle intervention for community-dwelling older adults: process evaluation of a stepped wedge trial. Implement Sci Commun. 2026 Jul 4. doi: 10.1186/s43058-026-01034-6. Online ahead of print.
PubMed 42401931
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.
- ClinicalTrials.gov ID
- NCT05672004
- Acronym / sponsor ID
- PUMP-fit / 22/050
- Conditions
- Sarcopenia, Frailty, Aging Problems
- Keywords
- implementation, lifestyle intervention, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Regiodeal Foodvalley
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 Jan 2023 (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 combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands.
Detailed description
ProMuscle is a combined lifestyle intervention that has been shown effective in improving muscle mass, muscle strength, and physical functioning in community-dwelling older adults. Potentially, it could facilitate older people in maintaining their functional independence.
Despite the promising results, ProMuscle is still not part of daily care. Previously factors influencing successful implementation were identified and implementation strategies targeting these factors were developed and formatted as an implementation toolbox for healthcare professionals.
To increase the likelihood of successful implementation of ProMuscle, this study aims to investigate the PUMP-fit strategy (implementation toolbox) effectiveness on the adoption of ProMuscle in community-care
A hybrid type 3 stepped wedge cluster trial with a mixed method analysis will be conducted to assess the effectiveness of the PUMP-fit implementation toolbox. A stepped wedge trail is chosen because of the ability to compare between clusters, but also within clusters.
Moreover, ProMuscle is already found effective, and the researchers hypothesized that the implementation toolbox should be assessable for all healthcare professionals in the 'Foodvalley'. At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect.
In addition, the researchers hypothesized that the program would be adapted to specific contexts' outcomes from the recipients of ProMuscle will be collected. A hybrid type three trial aims to investigate the implementation as a primary outcome and the effect of the (adapted) intervention as a secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped wedge cluster trial and mixed methods process analysis
| Arm | Type | Receives |
|---|---|---|
| Implementation as usual | Active comparator | Other: Implementation as usualHealthcare professionals will be instructed to implement ProMuscle in their practice as usual |
| PUMP-fit strategy: Implementation toolbox | Experimental | Other: PUMP-fit strategy (implementation toolbox)Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 65 years or older
- Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude)
- Able to understand Dutch
- Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength
Key exclusion criteria (1 listed)
- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner
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 |
|---|---|---|
| PUMP-fit strategy (implementation toolbox)Healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting (during the control period). Healthcare professionals will be informed about the platform and toolbox. Healthcare professionals receive a personal log-in for the online platform. Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible on the platform Within the separate environment of the online platform, healthcare professionals can access their implementation toolbox. The toolbox is tailored to their personal context based on the results of the 'Readinesstool'. | Other | PUMP-fit strategy: Implementation toolbox |
| Implementation as usualFirst, healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting. At the end of the training healthcare professionals are informed about the mandatory conditions to implement ProMuscle (champion, material, approval of management). Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible. Results contain a graph of possible barriers for implementation in their practice. Hereafter they will be instructed to start with implementation as usual. | Other | Implementation as usual |
Primary outcome
Adoption of ProMuscle
Time frame: 36 weeks
The number of healthcare professionals delivering ProMuscle is measured with administrative data and the REport of Sustainment Scale (PRESS). Because it is not possible to measure adoption at baseline, The Measure of Innovation-Specific Implementation Intentions (MISII) questionnaire will be used to measure adoptability (the attention to adopt an EBP) at T0
Fidelity of ProMuscle
Time frame: 36 weeks
Fidelity is the degree to which an intervention was implemented as prescribed. The number of activities described in the ProMuscle guideline executed by the healthcare professionals will be assessed with a self-report checklist based on the content of the ProMuscle intervention. Comparing the outcomes of fidelity before and after receiving the PUMP-fit strategy can indicate whether the toolbox contributed to the fidelity of delivery of ProMuscle.
16 secondary outcomes
Fidelity of the PUMP-fit strategy
Time frame: 24 weeks
Acceptability of the PUMP-fit strategy
Time frame: 36 weeks
Appropriateness of the PUMP-fit strategy
Time frame: 36 weeks
Feasibility of the PUMP-fit strategy
Time frame: 36 weeks
Barriers and facilitators for implementation of ProMuscle
Time frame: 36 weeks
Acceptability of ProMuscle
Time frame: 36 weeks
Appropriateness of ProMuscle
Time frame: 36 weeks
Feasibility of ProMuscle
Time frame: 36 weeks
Reach of ProMuscle
Time frame: 36 weeks
Sustainment of ProMuscle
Time frame: 54 weeks
Physical functioning recipients of ProMuscle
Time frame: 54 weeks
Functional lower extremity strength recipients of ProMuscle
Time frame: 54 weeks
Leg strength recipients of ProMuscle
Time frame: 54 weeks
Functional mobility recipients of ProMuscle 1RM
Time frame: 54 weeks
Care dependency recipients of ProMuscle
Time frame: 54 weeks
Lean body mass recipients ProMuscle
Time frame: 54 weeks
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 8 May 2024.
- Derived from this study: PubMed 42401931van der Laag PJ, Dorhout BG, Bos LR, Veenhof C, Barten DJ, Schoonhoven L. Exploring working mechanism of an implementation strategy bundle on the implementation of a lifestyle intervention for community-dwelling older adults: process evaluation of a stepped wedge trial. Implement Sci Commun. 2026 Jul 4. doi: 10.1186/s43058-026-01034-6. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Not yet recruitingObservational study
Sarcopenia Risk in Obese T2DM Patients
Sarcopenia, Obesity Type 2 Diabetes Mellitus
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
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.
Lisette Schoonhoven, prof principal investigator
Julius Center, University Medical Center Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUMP-fit strategy (implementation toolbox) and Implementation as usual in people with Sarcopenia and Frailty, run by UMC Utrecht 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 1 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 8 May 2024. 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?
Adoption of ProMuscle (time frame: 36 weeks). 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 NCT05672004, which also lists 1 linked publication.
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 8 May 2024.