Personalized Exercise Therapy and Self-management Support for Patients With Multimorbidity

Summary

Chronic conditions such as knee or hip osteoarthritis (OA), chronic obstructive pulmonary disease (COPD), heart failure (HF), coronary heart disease (CHD), hypertension, type 2 diabetes mellitus (T2DM) and depression are among the leading causes of global disability and affect hundreds of millions of people around the world. In recent years, multimorbidity, commonly defined as the co-occurrence of at least two chronic conditions, has also gained interest due to its substantial impact on the person and society.

Despite the significant burden of multimorbidity, little is known about how to treat this effectively. A 2016 Cochrane systematic review found that interventions targeting populations with specific combinations of conditions and addressing specific problems such as functional difficulties may be more effective. Exercise therapy is a treatment addressing functional limitations that is a safe and effective treatment of at least 26 chronic conditions, including OA, HF, CHD, hypertension, T2DM, COPD and depression. Furthermore, self-management support is increasingly recognized as an essential component of interventions to improve outcomes in patients living with multimorbidity and to support the long-term adherence to exercise. A new systematic review found that exercise seems effective in people with multimorbidity (the conditions included in the current study), however highlighting the need for further high-quality RCTs.

The aim of this randomized controlled trial (RCT) is to investigate the effects of a personalized exercise therapy and self-management support program in addition to usual care on self-reported, objectively measured and physiological outcomes in people with multimorbidity (i.e. at least two of the following conditions: OA (knee or hip), heart condition (HF or CHD), hypertension, T2DM, COPD and depression). The primary endpoint is 12 months, but 4- and 6-month follow-ups are included as well and a 12-month health economic evaluation of the program will be conducted.

Prior to the RCT, a feasibility trial of 20 people with multimorbidity, all undergoing the personalized exercise therapy and self-management support program, will be conducted using the same methods as in the RCT, but primarily focusing on feasibility outcomes (recruitment, retention, adherence to treatment, burden of outcomes, improvements in outcomes, adverse events). This will start recruitment in Feb 2021 and end August 2021.

The MOBILIZE project has received funding from several foundations, including the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation program (grant agreement No 801790).

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip
• Heart Failure
• Coronary Heart Disease
• Hypertension
• Type2 Diabetes
• Chronic Obstructive Pulmonary Disease
• Depression

Interventions

BEHAVIORAL

Personalized exercise therapy and self-management support program

See description under Arms

OTHER

Usual care

See description under Arms

Sponsors & Collaborators

• Naestved Hospital

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Lolland Municipality

  collaborator UNKNOWN

• Roskilde Municipality

  collaborator UNKNOWN

• Psychiatric Hospital West, Slagelse

  collaborator UNKNOWN

• Næstved, Slagelse and Ringsted Hospitals' Research Fund

  collaborator UNKNOWN

• Association of Danish Physiotherapists

  collaborator OTHER

• The Danish Health Confederation through the Development and Research Fund

  collaborator UNKNOWN

• European Research Council

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Nykøbing Falster County Hospital

  collaborator OTHER

• FysioDanmark Holbæk

  collaborator UNKNOWN

• Zealand University Hospital

  collaborator OTHER

• Lægerne Reventlow og Wolfhagen, Slagelse

  collaborator UNKNOWN

• Lægerne Algade 17, Roskilde

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Søren T Skou, PT, MSc, PhD · Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

• Uffe Bødtger, MD · Department of Pulmonology, Næstved Hospital

• Peter Gæde, MD · Department of Cardiology and Endocrinology, Slagelse Hospital

• Manuel J Bieder, MD · Department of Orthopaedic Surgery, Næstved Hospital

• Sidse Arnfred, MD · Psychiatric Hospital West, Slagelse

• Christine Bodilsen, PT, MSc, PhD · Municipality of Roskilde

• Jan A Overgaard, PT, MSc · Municipality of Lolland

• Alessio Bricca, MSc, PhD · Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

• Madalina Jäger, MSc, PhD · Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

• Christian S Christiansen, MD · Nykøbing Falster County Hospital

• Anne Merete B Soja, MD, PhD, DMSc · Holbaek Sygehus

• Niels Eske Bruun, MD · Department of Cardiology, Zealand University Hospital, Roskilde

• Johan L Reventlow, MD · Lægerne Reventlow og Wolfhagen, Slagelse

• Andreas Heltberg, MD, PhD · Lægerne Algade 17, Roskilde

• Lau C Thygesen, MSc, PhD · University of Southern Denmark

• Poul Erik Holst, MD · Læge Poul Erik Holst, Holbæk

• Rita M Andersen, MSc · Psychiatric Clinic Næstved

• Amir Pasha Attarzadeh, MD · Department of Orthopedics, Zealand University Hospital, Køge

• Mickey T Kongerslev, MSc · Community Psychiatry Roskilde

• Louise Richelieu, MD · Lægehuset Tolskovvej, Hvalsø

• Signe Aspelin, MD · Lægehuset Ostenfeldt, Næstved

• Sille Capion, MD · Lægehuset Ostenfeldt, Næstved

• Rune F Nielsen, Nurse · Community Clinic Nakskov

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2024-07-31

Completion

2024-07-31

Countries

• Denmark

Study Locations