Clinical trial NCT05672004: Implementation of ProMuscle in Daily Practice
Official title: Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frailty
Aging Problems
Keywords: implementation
lifestyle intervention
prevention
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Regiodeal Foodvalley
First posted: 2023-01-05
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: stepped wedge cluster trial and mixed methods process analysis
Primary purpose: 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.

Eligibility 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

Exclusion criteria:

- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner

Primary outcomes:
measure: Adoption of ProMuscle
timeFrame: 36 weeks
measure: Fidelity of ProMuscle
timeFrame: 36 weeks
Secondary outcomes:
measure: Fidelity of the PUMP-fit strategy
timeFrame: 24 weeks
measure: Acceptability of the PUMP-fit strategy
timeFrame: 36 weeks
measure: Appropriateness of the PUMP-fit strategy
timeFrame: 36 weeks
measure: Feasibility of the PUMP-fit strategy
timeFrame: 36 weeks
measure: Barriers and facilitators for implementation of ProMuscle
timeFrame: 36 weeks
measure: Acceptability of ProMuscle
timeFrame: 36 weeks
measure: Appropriateness of ProMuscle
timeFrame: 36 weeks
measure: Feasibility of ProMuscle
timeFrame: 36 weeks
measure: Reach of ProMuscle
timeFrame: 36 weeks
measure: Sustainment of ProMuscle
timeFrame: 54 weeks
measure: Physical functioning recipients of ProMuscle
timeFrame: 54 weeks
measure: Functional lower extremity strength recipients of ProMuscle
timeFrame: 54 weeks
measure: Leg strength recipients of ProMuscle
timeFrame: 54 weeks
measure: Functional mobility recipients of ProMuscle 1RM
timeFrame: 54 weeks
measure: Care dependency recipients of ProMuscle
timeFrame: 54 weeks
measure: Lean body mass recipients ProMuscle
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Julius Center, University Medical Center Utrecht, The Netherlands
name: Lisette Schoonhoven, prof
role: PRINCIPAL_INVESTIGATOR
References: