NCT04645732Befejeződött
Personalized Exercise Therapy and Self-management Support for Patients With Multimorbidity
Improving Health in People With Multimorbidity: a Paradigm Shift in Health Care From Disease-based Curative Models to Personalized Exercise Therapy and Self-management
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 23.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 228 (tényleges)
- Első benyújtás
- 2020. nov. 2.
- Kezdés
- 2021. nov. 1.
- Elsődleges befejezés
- 2024. júl. 31.
- Fő szponzor
- University of Southern Denmark
- Betegségek
- Szívelégtelenség, Koszorúér-betegség, Magas vérnyomás, Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT04645732
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 228
- 2021. nov. 1. és az elsődleges befejezés (2024. júl. 31.) között
- 16 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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
- 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
Egyéb
- Terminal patients and patients with life expectancy of less than 12 months
- Other reasons (unable to understand Danish, mentally unable to participate, etc.)
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (16)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Læge Poul Erik Holst | Holbæk | Dánia | Ismeretlen állapot |
| Holbæk Sygehus | Holbæk | Dánia | Ismeretlen állapot |
| Lægehuset Tolskovvej | Kirke Hvalsø | Dánia | Ismeretlen állapot |
| Department of Orthopedics, Zealand University Hospital | Køge | Dánia | Ismeretlen állapot |
| Lægehuset Ostenfeldt | Næstved | Dánia | Ismeretlen állapot |
| Psychiatric Clinic Næstved | Næstved | Dánia | Ismeretlen állapot |
| Department of Orthopaedic Surgery, Næstved Hospital | Næstved | Dánia | Ismeretlen állapot |
| Department of Pulmonology, Næstved Hospital | Næstved | Dánia | Ismeretlen állapot |
| Community Clinic | Nakskov | Dánia | Ismeretlen állapot |
| Lægerne Algade 17 | Roskilde | Dánia | Ismeretlen állapot |
| Department of Cardiology, Zealand University Hospital | Roskilde | Dánia | Ismeretlen állapot |
| Community Psychiatry Roskilde | Roskilde | Dánia | Ismeretlen állapot |
| Department of Cardiology and Endocrinology, Slagelse Hospital | Slagelse | Dánia | Ismeretlen állapot |
| Nykøbing Falster County Hospital | Slagelse | Dánia | Ismeretlen állapot |
| Psychiatric Hospital West, Slagelse | Slagelse | Dánia | Ismeretlen állapot |
| Lægerne Reventlow og Wolfhagen | Slagelse | Dánia | Ismeretlen állapot |
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