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Implementation of ProMuscle in Daily Practice

Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05672004
Acronym
PUMP-fit
Enrollment
27
Registered
2023-01-05
Start date
2022-12-01
Completion date
2024-05-01
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Problems, Frailty, Sarcopenia

Keywords

implementation, lifestyle intervention, prevention

Brief 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.

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.

Interventions

OTHERPUMP-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'.

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.

Sponsors

Regiodeal Foodvalley
CollaboratorUNKNOWN
UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Recipients of ProMuscle are not the target group within this study. Healthcare professionals are the participants of the study, they know that they received the implementation toolbox once they switched to the intervention group

Intervention model description

stepped wedge cluster trial and mixed methods process analysis

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

To be eligible to participate in this study, healthcare professionals must met the following criteria: * Physical therapist, lifestyle coach or dietician in one of the communities in the Foodvalley in the Netherlands * Interested in combined lifestyle programs for older adults * Frequently involved in maintaining physical functioning in older adults In and

Exclusion criteria

for older residents receiving ProMuscle are: Inclusion criteria: * 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

Design outcomes

Primary

MeasureTime frameDescription
Adoption of ProMuscle36 weeksThe 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 ProMuscle36 weeksFidelity 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.

Secondary

MeasureTime frameDescription
Appropriateness of the PUMP-fit strategy36 weeksAppropriateness 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.
Feasibility of the PUMP-fit strategy36 weeksFeasibility 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.
Barriers and facilitators for implementation of ProMuscle36 weeksBarriers 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.
Acceptability of ProMuscle36 weeksAcceptability 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
Appropriateness of ProMuscle36 weeksAppropriateness 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.
Feasibility of ProMuscle36 weeksFeasibility 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
Reach of ProMuscle36 weeksReach is defined as the number of older adults and will be measured by administrative data.
Fidelity of the PUMP-fit strategy24 weeksFidelity 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.
Physical functioning recipients of ProMuscle54 weeksThe Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.
Functional lower extremity strength recipients of ProMuscle54 weeksRepeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.
Leg strength recipients of ProMuscle54 weeksThe 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.
Functional mobility recipients of ProMuscle 1RM54 weeksFunctional mobility is measured with the Timed-Up-And-Go test (TUG).
Care dependency recipients of ProMuscle54 weeksHealthcare 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.
Lean body mass recipients ProMuscle54 weeksLean body mass is measured with the bioelectrical impedance analysis (BIA)
Sustainment of ProMuscle54 weeksSustainment 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.
Acceptability of the PUMP-fit strategy36 weeksAcceptability 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 6, 2026