TY - JOUR

T1 - Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity

T2 - The MOBILIZE study

AU - Skou, Søren T

AU - Nyberg, Mette

AU - Dideriksen, Mette

AU - Overgaard, Jan A

AU - Bodilsen, Christine

AU - Soja, Anne Mb

AU - Attarzadeh, Amir P

AU - Bieder, Manuel J

AU - Dridi, Nadia P

AU - Heltberg, Andreas

AU - Gæde, Peter H

AU - Reventlow, Johan L

AU - Arnfred, Sidse

AU - Bodtger, Uffe

AU - Thygesen, Lau C

AU - Jäger, Madalina

AU - Bricca, Alessio

N1 - © The Author(s) 2023.

PY - 2023

Y1 - 2023

N2 - BACKGROUND: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it.OBJECTIVE: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity.DESIGN: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience.DISCUSSION: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

AB - BACKGROUND: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it.OBJECTIVE: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity.DESIGN: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience.DISCUSSION: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

U2 - 10.1177/26335565231154447

DO - 10.1177/26335565231154447

M3 - Journal article

C2 - 36762033

VL - 13

JO - J Multimorb Comorb .

JF - J Multimorb Comorb .

SN - 2633-5565

ER -