Implementation of ProMuscle in Daily Practice (PUMP-fit)

UMC Utrecht

Status: Completed

Conditions: Aging Problems; Frailty; Sarcopenia

Treatments: Other: PUMP-fit strategy (implementation toolbox); Other: Implementation as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05672004

22/050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Implementation as usual

Active Comparator group

Description:

Healthcare professionals will be instructed to implement ProMuscle in their practice as usual

Treatment:

Other: Implementation as usual

PUMP-fit strategy: Implementation toolbox

Experimental group

Description:

Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation

Treatment:

Other: PUMP-fit strategy (implementation toolbox)