The Bern Rehab Registry

NCT06516172 | Recruiting DMC

• 1 other identifier: 2024-00480
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 2

Brief Summary

This study examines the health outcomes of patients with long-term illnesses such as cancer, heart, lung, or musculoskeletal diseases who participate in a rehabilitation programme. The programme may involve staying in a facility (inpatient), visiting a facility (outpatient), home-based care supported by digital health tools (telerehabilitation), or a combination of facility- and home-based options. The key health outcomes being measured include physical fitness and strength, body composition (like body fat and muscle mass), specific risk factors related to the diseases, and patients' self-reported health and experience outcomes, such as feelings of anxiety, depression, fatigue, overall quality of life, and satisfaction with the rehabilitation programme. These measurements provide important information about the patients' lung, heart, and muscle health, as well as their mental well-being. They also help to predict the likelihood of further health complications, the chance of needing to be hospitalized again, and overall quality of life. This information is useful for improving the quality of care, tailoring future provision of rehabilitation services and long-term care for patients with chronic conditions. Additionally, the study will provide insights into how new technologies like telerehabilitation are implemented, including how well they are adopted, followed, and accepted by patients.

Conditions

Cancer; Cardiovascular Diseases; Musculoskeletal Diseases; Pulmonary Disease

Keywords

Rehabilitation; Prevention; Physical Function; Mental Function; Participation; Disabilities

Outcome Measures

Primary Outcomes (2)

• Short-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)

  Stratified by type of delivery and cohort

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)

• Long-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)

  Stratified by type of delivery and cohort

  From discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) to one year follow-up

Secondary Outcomes (20)

• Short- and long-term change (absolute and percentage) in muscle strength, measured by grip strength (kg)

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up

• Short- and long-term change (absolute and percentage) in muscle mass index, measured by body impedance analysis (kg/height2)

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up

• Short- and long-term change (absolute and percentage) in the Extended Barthel Index (EBI, range from 0 to 64) or the Functional Independence Measure (FIM, range from 0 to 126), higher values indicate better levels physical and/or mental functioning

  From rehabilitation entry to discharge (3 weeks) and from discharge to one year follow-up

• Short- and long-term changes (absolute and percentage) in markers of anxiety, measured by Generalized Anxiety Disorder-7 questionnaire score (range from 0 to 21, higher values indicate more severe anxiety)

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up

• Short- and long-term changes (absolute and percentage) in markers of depression, measured by Patient Health Questionnaire-9 score (range from 0 to 27, higher values indicate more severe depression)

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up

Other Outcomes (2)

• Time trends of proportion of patient participating in digitally-enhanced or digital/telerehabilitation (percentage)

  12 months

• Assessment of patient reported experience measures (PREMS) by a self-designed questionnaire on satisfaction with the rehabilitation programme (range 1 to 10, higher values indicate higher satisfaction)

  From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)

Study Arms (4)

Patients with cancer

Age 18+ years, indication for cancer rehabilitation

Other: Comprehensive disease-specific rehabilitation

Patients with cardiovascular diseases

Age 18+ years, indication for cardiovascular rehabilitation

Other: Comprehensive disease-specific rehabilitation

Patients with musculoskeletal diseases

Age 18+ years, indication for musculoskeletal rehabilitation

Other: Comprehensive disease-specific rehabilitation

Patients with pulmonary diseases

Age 18+ years, indication for pulmonary rehabilitation

Other: Comprehensive disease-specific rehabilitation

Interventions

Comprehensive disease-specific rehabilitation OTHER

Participation in (a) inpatient rehabilitation, (b) outpatient centre-based, (c) outpatient digitally-enhanced centre- and home-based, or (d) outpatient home-based digital/tele rehabilitation. Duration is 3 weeks for inpatient and 12 weeks for outpatient programmes.

Patients with cancer; Patients with cardiovascular diseases; Patients with musculoskeletal diseases; Patients with pulmonary diseases

Eligibility Criteria

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

Study Population

Patients with chronic, non-communicable diseases participating in a comprehensive disease-specific rehabilitation program.

You may qualify if:

• Patients aged 18 years and older with a chronic non-communicable disease
• Signed general informed consent
• Referral to a comprehensive disease-specific rehabilitation program

You may not qualify if:

• Refuted or missing general informed consent for further use of health-related data and samples.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Berner Reha Centre, Centre for Rehabilitation & Sports Medicine, Insel Group

Heiligenschwendi, Canton of Bern, 3625, Switzerland

RECRUITING

Reha Inselspital, Bern University Hospital, Centre for Rehabilitation & Sports Medicine, Insel Group

Bern, 3010, Switzerland

RECRUITING

Related Links

• Website of the Centre for Rehabilitation \& Sports Medicine, Insel Group Bern

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases; Musculoskeletal Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Matthias Wilhelm, MD

  Centre for Rehabilitation & Sports Medicine, Insel Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Wilhelm, MD

CONTACT

+41 31 632 8986; matthias.wilhelm@insel.ch

Prisca Eser, PhD

CONTACT

+41 31 632 4398; prisca.eser@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 23, 2024
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)