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Clinical Trial NCT06516172 (BernRehabReg) for Cancer, Cardiovascular Diseases, Musculoskeletal Diseases, Pulmonary Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Bern Rehab Registry (BernRehabReg) 30,000 Home-Based Digital Health
Clinical Trial NCT06516172 (BernRehabReg) is an observational study for Cancer, Cardiovascular Diseases, Musculoskeletal Diseases, Pulmonary Disease that is recruiting. It started on 1 December 2020 with plans to enroll 30,000 participants. Led by Insel Gruppe AG, University Hospital Bern, it is expected to complete by 1 December 2030. The latest data from ClinicalTrials.gov was last updated on 19 August 2024.
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 ou...
Show MoreDetailed Description
Background:
The global demographic landscape is shifting towards an aging population, coupled with a rise in chronic, non-communicable diseases that contribute to disability and escalating healthcare costs. Recognizing this, the World Health Organization (WHO) has identified rehabilitation as a key strategy for health in the 21st century.
Aim:
The aim of this prospective cohort study is to assess the outcomes of d...
Show MoreOfficial Title
The Bern Rehab Registry - a Prospective Cohort Study in Patients With Chronic Non-communicable Diseases Participating in a Comprehensive Rehabilitation Programme
Conditions
CancerCardiovascular DiseasesMusculoskeletal DiseasesPulmonary DiseaseOther Study IDs
- BernRehabReg
- 2024-00480
NCT ID Number
Start Date (Actual)
2020-12-01
Last Update Posted
2024-08-19
Completion Date (Estimated)
2030-12
Enrollment (Estimated)
30,000
Study Type
Observational
Status
Recruiting
Keywords
Rehabilitation
Prevention
Physical Function
Mental Function
Participation
Disabilities
Prevention
Physical Function
Mental Function
Participation
Disabilities
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Patients with cancer Age 18+ years, indication for cancer rehabilitation | Comprehensive disease-specific rehabilitation 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 cardiovascular diseases Age 18+ years, indication for cardiovascular rehabilitation | Comprehensive disease-specific rehabilitation 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 musculoskeletal diseases Age 18+ years, indication for musculoskeletal rehabilitation | Comprehensive disease-specific rehabilitation 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 pulmonary diseases Age 18+ years, indication for pulmonary rehabilitation | Comprehensive disease-specific rehabilitation 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Short- and long-term change (absolute and percentage) in muscle strength, measured by grip strength (kg) | Stratified by type of delivery and cohort | 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) | Stratified by type of delivery and cohort | 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 | In patients participating in inpatient rehabilitation, stratified by cohort | 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) | Stratified by type of delivery and cohort | 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) | Stratified by type of delivery and cohort | 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 health-related quality of life, measured by Kansas City Cardiomyopathy Questionnaire-23 score (range from 0 to 100, higher values indicate better QoL) | In patients with heart failure, stratified by type of delivery | 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 health-related quality of life, measured by HearQoL questionnaire score (range from 0 to 3, higher values indicate better QoL) | In patients with heart disease participating in outpatient cardiac rehabilitation or telerehabilitation | 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 health-related quality of life, measured by MacNew questionnaire score (range 0 to 7, higher values indicate better QoL) | In patients with heart disease participating in inpatient cardiac rehabilitation | 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 health-related quality of life, measured by Chronic Respiratory Disease Questionnaire score (range 1 to 7, higher values indicate better QoL) | In patients with pulmonary disease, stratified by type of delivery | 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 health-related quality of life, measured by Functional Assessment of Cancer Therapy-General questionnaire score (range 1 to 5, higher values indicate better QoL) | In patients with cancer, stratified by type of delivery | 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 office systolic blood pressure (mmHg) | Stratified by type of delivery and cohort | 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 LDL-cholesterol (mmol/l) | Stratified by type of delivery and cohort | 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 HbA1c (percentage) | Composite outcome, stratified by type of delivery and cohort | 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 hsCRP (mg/l) | Stratified by type of delivery and cohort | 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 body mass index (kg/m2) | Stratified by type of delivery and cohort | 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 body fat, assessed by body impedance analysis (%) | Stratified by type of delivery and cohort | 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 steps per day, assessed by wrist-worn accelerometer (n) | Stratified by type of delivery and cohort | 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 smoking status, assessed by questionnaire (current, former, non-smoker) | Composite outcome, stratified by type of delivery and cohort | 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 adherence to guideline-directed medical therapies (percentage of recommended medical substances taken) | Stratified by type of delivery and cohort | From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up |
Return to work (yes, no) | Stratified by type of delivery and cohort | At rehabilitation discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and at one year follow-up |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients aged 18 years and older with a chronic non-communicable disease
- Signed general informed consent
- Referral to a comprehensive disease-specific rehabilitation program
- Refuted or missing general informed consent for further use of health-related data and samples.
Insel Gruppe AG, University Hospital BernStudy Central Contact
Contact: Matthias Wilhelm, MD, +41 31 632 8986, [email protected]
Contact: Prisca Eser, PhD, +41 31 632 4398, [email protected]
2 Study Locations in 1 Countries
Canton of Bern
Berner Reha Centre, Centre for Rehabilitation & Sports Medicine, Insel Group, Heiligenschwendi, Canton of Bern, 3625, Switzerland
Thimo Marcin, PhD, Contact, +41 33 244 33 33, [email protected]
Recruiting
Reha Inselspital, Bern University Hospital, Centre for Rehabilitation & Sports Medicine, Insel Group, Bern, 3010, Switzerland
Prisca Eser, PhD, Contact, +41 32 632 4398, [email protected]
Recruiting