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

NCT04645732 | Completed DMC

• 2 other identifiers: SJ-857801790
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

Exercise; Self-management; Clinical Trial; Multimorbidity; Evaluation

Outcome Measures

Primary Outcomes (1)

• EQ-5D-5L, the descriptive index

  The descriptive index of the EuroQol-5 Domain 5-level questionnaire (EQ-5D-5L) measures the patient's self-rated health status. Ranging from -0.757 to 1, higher is better. This will also allow for a later cost-effectiveness analysis. Assessed at baseline, 4, 6 and 12 months. All visits (baseline, 4, 6 and 12 months) will be included in the analysis.

  Primary endpoint: Change from baseline to 12 months

Secondary Outcomes (12)

• 6-minute walk test

  Primary endpoint: Change from baseline to 12 months

• Burden of illness measure

  Primary endpoint: Change from baseline to 12 months

• 30-second chair-stand test

  Primary endpoint: Change from baseline to 12 months

• Depression Scale

  Primary endpoint: Change from baseline to 12 months

• Anxiety

  Primary endpoint: Change from baseline to 12 months

Other Outcomes (48)

• Isometric knee-extension strength

  Primary endpoint: Change from baseline to 12 months

• Balance

  Primary endpoint: Change from baseline to 12 months

• Pain (yes/no) in left and right knee and hip + worst joint if more than one

  Primary endpoint: Change from baseline to 12 months

Study Arms (2)

Personalized exercise therapy and self-management program in addition to usual care

EXPERIMENTAL

Participants randomized to the personalized exercise therapy and self-management support program will participate in a 12-week program tailored to people with multimorbidity at one of the intervention sites. The program will consist of 24 exercise therapy and self-management sessions distributed across the program (twice weekly, each lasting around 1.5 hour). Furthermore, this group will receive the treatment described under usual care below.

Behavioral: Personalized exercise therapy and self-management support program; Other: Usual care

Usual care alone

ACTIVE COMPARATOR

Usual care is the care that the participants would receive had they not participated in the study, i.e. treatments or services that are routinely provided in the settings from which the participants are recruited. Participants will continue their current treatment, if needed, and be allowed to receive other treatments if their general practitioner or specialist finds it relevant for their particular comorbidities.

Other: Usual care

Interventions

Personalized exercise therapy and self-management support program BEHAVIORAL

See description under Arms

Personalized exercise therapy and self-management program in addition to usual care

Usual care OTHER

See description under Arms

Personalized exercise therapy and self-management program in addition to usual care; Usual care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least two of the following conditions: OA (knee or hip), COPD, heart condition (HF or CHD), hypertension, T2DM, depression (having other comorbidities does not exclude a patient)
• Adults aged 18 years or above
• Able to walk 3 meters without any assistance
• A score of 3 or above on the Bayliss' Disease Burden: Morbidity Assessment by Self- Report scale for at least one of the conditions listed above and a score of 2 or above for at least one of the other listed conditions
• Willingness and ability to participate in a 12-week supervised exercise therapy and self- management support program twice a week

You may not qualify if:

• Participation in supervised systematic exercise for one of their diseases within the last 3 months
• Patients with an unstable health condition or at risk of serious adverse events as evaluated by a medical specialist
• Patients categorized as Class IV on the New York Heart Association (NYHA) Functional Classification scale
• Terminal patients and patients with life expectancy of less than 12 months
• Patients with psychosis disorders, post-traumatic stress disorder, Obsessive Compulsive Disorder, attention deficit hyperactivity disorder, autism, anorexia nervosa/bulimia nervosa and patients with dependency disorders
• Other reasons (unable to understand Danish, mentally unable to participate, etc.)

Sponsors & Collaborators

• University of Southern Denmark: lead
• Naestved Hospital: collaborator
• Slagelse Hospital: collaborator
• Lolland Municipality: collaborator
• Roskilde Municipality: collaborator
• Psychiatric Hospital West, Slagelse: collaborator
• Næstved, Slagelse and Ringsted Hospitals' Research Fund: collaborator
• Association of Danish Physiotherapists: collaborator
• The Danish Health Confederation through the Development and Research Fund: collaborator
• European Research Council: collaborator
• Holbaek Sygehus: collaborator
• Nykøbing Falster County Hospital: collaborator
• FysioDanmark Holbæk: collaborator
• Zealand University Hospital: collaborator
• Lægerne Reventlow og Wolfhagen, Slagelse: collaborator
• Lægerne Algade 17, Roskilde: collaborator

Study Sites (16)

Holbæk Sygehus

Holbæk, Denmark

Location

Læge Poul Erik Holst

Holbæk, Denmark

Location

Lægehuset Tolskovvej

Kirke Hvalsø, Denmark

Location

Department of Orthopedics, Zealand University Hospital

Køge, Denmark

Location

Community Clinic

Nakskov, Denmark

Location

Department of Orthopaedic Surgery, Næstved Hospital

Næstved, Denmark

Location

Department of Pulmonology, Næstved Hospital

Næstved, Denmark

Location

Lægehuset Ostenfeldt

Næstved, Denmark

Location

Psychiatric Clinic Næstved

Næstved, Denmark

Location

Community Psychiatry Roskilde

Roskilde, Denmark

Location

Department of Cardiology, Zealand University Hospital

Roskilde, Denmark

Location

Lægerne Algade 17

Roskilde, Denmark

Location

Department of Cardiology and Endocrinology, Slagelse Hospital

Slagelse, 4200, Denmark

Location

Lægerne Reventlow og Wolfhagen

Slagelse, 4200, Denmark

Location

Psychiatric Hospital West, Slagelse

Slagelse, 4200, Denmark

Location

Nykøbing Falster County Hospital

Slagelse, Denmark

Location

Related Publications (2)

• Skou ST, Nyberg M, Dideriksen M, Rasmussen H, Overgaard JA, Bodilsen C, Soja AMB, Attarzadeh AP, Bieder MJ, Dridi NP, Heltberg A, Gaede PH, Reventlow JL, Arnfred S, Bodtger U, Brond JC, Thygesen LC, Moller SP, Jager M, Bricca A. Exercise therapy and self-management support for individuals with multimorbidity: a randomized and controlled trial. Nat Med. 2025 Sep;31(9):3176-3182. doi: 10.1038/s41591-025-03779-4. Epub 2025 Jun 30.

  PMID: 40588675 DERIVED

• Skou ST, Brodsgaard RH, Nyberg M, Dideriksen M, Bodtger U, Bricca A, Jager M. Personalised exercise therapy and self-management support for people with multimorbidity: feasibility of the MOBILIZE intervention. Pilot Feasibility Stud. 2023 Jan 18;9(1):12. doi: 10.1186/s40814-023-01242-0.

  PMID: 36653858 DERIVED

Related Links

• Open Science Framework platform for MOBILIZE
• MOBILIZE webpage

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Heart Failure; Coronary Disease; Hypertension; Pulmonary Disease, Chronic Obstructive; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Søren T Skou, PT, MSc, PhD

  Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Uffe Bødtger, MD

  Department of Pulmonology, Næstved Hospital

  STUDY CHAIR

• Peter Gæde, MD

  Department of Cardiology and Endocrinology, Slagelse Hospital

  STUDY CHAIR

• Manuel J Bieder, MD

  Department of Orthopaedic Surgery, Næstved Hospital

  STUDY CHAIR

• Sidse Arnfred, MD

  Psychiatric Hospital West, Slagelse

  STUDY CHAIR

• Christine Bodilsen, PT, MSc, PhD

  Municipality of Roskilde

  STUDY CHAIR

• Jan A Overgaard, PT, MSc

  Municipality of Lolland

  STUDY CHAIR

• Alessio Bricca, MSc, PhD

  Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

  STUDY CHAIR

• Madalina Jäger, MSc, PhD

  Næstved, Slagelse and Ringsted hospital and University of Southern Denmark

  STUDY CHAIR

• Christian S Christiansen, MD

  Nykøbing Falster County Hospital

  STUDY CHAIR

• Anne Merete B Soja, MD, PhD, DMSc

  Holbaek Sygehus

  STUDY CHAIR

• Niels Eske Bruun, MD

  Department of Cardiology, Zealand University Hospital, Roskilde

  STUDY CHAIR

• Johan L Reventlow, MD

  Lægerne Reventlow og Wolfhagen, Slagelse

  STUDY CHAIR

• Andreas Heltberg, MD, PhD

  Lægerne Algade 17, Roskilde

  STUDY CHAIR

• Lau C Thygesen, MSc, PhD

  University of Southern Denmark

  STUDY CHAIR

• Poul Erik Holst, MD

  Læge Poul Erik Holst, Holbæk

  STUDY CHAIR

• Rita M Andersen, MSc

  Psychiatric Clinic Næstved

  STUDY CHAIR

• Amir Pasha Attarzadeh, MD

  Department of Orthopedics, Zealand University Hospital, Køge

  STUDY CHAIR

• Mickey T Kongerslev, MSc

  Community Psychiatry Roskilde

  STUDY CHAIR

• Louise Richelieu, MD

  Lægehuset Tolskovvej, Hvalsø

  STUDY CHAIR

• Signe Aspelin, MD

  Lægehuset Ostenfeldt, Næstved

  STUDY CHAIR

• Sille Capion, MD

  Lægehuset Ostenfeldt, Næstved

  STUDY CHAIR

• Rune F Nielsen, Nurse

  Community Clinic Nakskov

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators, outcome assessors and the statistician will be blinded to randomization. Furthermore, a blinded interpretation of the study results will be conducted
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The RCT is a pragmatic, parallel-group, superiority RCT (1:1 ratio)

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 27, 2020
• Study Start: November 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Ultimo 2024.
• Access Criteria: Data will be made available upon reasonable request after the primary publications have been published.

Locations

DK (16)