Framework of the MOBILIZE project

The project has four phases, see Figure 1.

Figure 1 Overall framework for developing and evaluating complex interventions 

Phase 1
Development of a tailored exercise and education program

During the first part of the project, outcomes and biomarkers that predict better health outcome from different types of exercise therapy and exercise characteristics associated with a better outcome in people with different combinations of chronic conditions will be identified through an exploratory observational cohort study of people with osteoarthritis who have undergone an 8-week exercise therapy and education program in Denmark (GLA:D®) as well as two systematic reviews and meta-analyses that summarize the existing evidence – one will identify self-reported and objectively measured predictors of treatment effect and exercise associated with a better outcome in patients with multimorbidity and one will investigate the behaviour change techniques that underlie exercise trials that have a patient education (or self-management component) designed for people who live with multimorbidity.

A 12-week exercise therapy and education program will subsequently be developed based on existing recommendations for exercise and strategies to facilitate behavioral changes. To ensure a high degree of patient and provider involvement, focus group interviews will be conducted with patients with multimorbidity, health care providers and other relevant stakeholders to acquire their views on the program.

Phase 2
Feasibility trial

Once phase 1 is completed, the exercise therapy and education program will be tested in a feasibility trial involving 30 patients with multimorbidity. The same procedures and outcomes as in the subsequent RCT will be used, and data will be collected at baseline and immediately after the intervention (12 weeks). The lessons from the feasibility trial will be used to evaluate and implement any adjustments that need to be made prior to commencing the RCT.

Phase 3
Effects of the tailored exercise therapy and education program

The purpose of the RCT is to investigate the effects of a tailored exercise therapy and education program in comparison with current best practice on self-reported, objectively measured and physiological outcomes in people with multimorbidity. Two hundred and twenty-eight participants fulfilling the eligibility criteria will be recruited from hospitals and municipal rehabilitation centers in Region Zealand. The included patients will be randomized to either the tailored exercise therapy and education program or current best practice. Data will be collected at baseline and after 12 weeks. The study hypothesis is that the tailored exercise therapy and education program will improve quality of life and physical function more than current best practice.

Phase 4
Implementation in clinical practice

If supported by study findings, a model for implementation of the tailored exercise therapy and education program in clinical practice will be developed during the last phase of the MOBILIZE project. For further information, see section on Dissemination & Impact.