CancerBernRehabRegNCT06516172
The Bern Rehab Registry
An observational study of Cancer and Cardiovascular Diseases, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cardiovascular Diseases, Musculoskeletal Diseases
- What is being tested?
- Comprehensive disease-specific rehabilitation
- How many people
- 30,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Dec 2020to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic, non-communicable diseases participating in a comprehensive disease-specific rehabilitation program.
Who may be able to join
- Patients aged 18 years and older with a chronic non-communicable disease
- Signed general informed consent
- Referral to a comprehensive disease-specific rehabilitation program
Who cannot join
- Refuted or missing general informed consent for further use of health-related data and samples.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Reha Inselspital, Bern University Hospital, Centre for Rehabilitation & Sports Medicine, Insel Group
Bern, 3010
Prisca Eser, PhD, +41 32 632 4398, prisca.eser@insel.ch
- Recruiting
Berner Reha Centre, Centre for Rehabilitation & Sports Medicine, Insel Group
Heiligenschwendi, Canton of Bern, 3625
Thimo Marcin, PhD, +41 33 244 33 33, t.marcin@rehabern.ch
About this study
Official title: The Bern Rehab Registry - a Prospective Cohort Study in Patients With Chronic Non-communicable Diseases Participating in a Comprehensive Rehabilitation Programme
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.
Read more
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.
Read the detailed 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 disease-specific comprehensive rehabilitation programmes at a tertiary referral center to improve the quality of care and formulate novel research questions.
Methods:
Consecutive patients with cancer, cardiovascular, musculoskeletal, or pulmonary diseases, referred for comprehensive rehabilitation to the Centre for Rehabilitation \& Sports Medicine (two locations - Berner Reha Centre and Inselspital) of the Insel Group, Bern, Switzerland, will be included. Patients will be counselled by trained advanced practice nurses, and type of delivery of the rehabilitation programme will be based on medical needs and patient preferences. Three-week inpatient programmes are performed at the Berner Reha Centre and Inselspital. Twelve-week outpatient programmes are performed at the Inselspital and delivered as centre-based, digitally-enhanced centre- and home-based, or home-based digital/tele rehabilitation.
Outcome assessments will be based on the framework of the International Classification of Functioning, Disability, and Health (ICF) of the World Health Organisation.
- Being tested
- Comprehensive disease-specific rehabilitation
- Keywords
- Rehabilitation, Prevention, Physical Function, Mental Function, Participation, Disabilities
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Musculoskeletal Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive disease-specific rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer | Age 18+ years, indication for cancer rehabilitation Receives: Other: Comprehensive disease-specific rehabilitation | |
| Patients with cardiovascular diseases | Age 18+ years, indication for cardiovascular rehabilitation Receives: Other: Comprehensive disease-specific rehabilitation | |
| Patients with musculoskeletal diseases | Age 18+ years, indication for musculoskeletal rehabilitation Receives: Other: Comprehensive disease-specific rehabilitation | |
| Patients with pulmonary diseases | Age 18+ years, indication for pulmonary rehabilitation Receives: Other: Comprehensive disease-specific rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Stratified by type of delivery and cohort
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At rehabilitation discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and at one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Dec 2020
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Wilhelm, MD, Principal investigator, Centre for Rehabilitation & Sports Medicine, Insel Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516172
- Sponsor's protocol ID
- 2024-00480
- Acronym
- BernRehabReg
- Status last verified
- Aug 2024
- First submitted
- 28 May 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bern Rehab Registry - a Prospective Cohort Study in Patients With Chronic Non-communicable Diseases Participating in a Comprehensive Rehabilitation Programme
- ClinicalTrials.gov ID
- NCT06516172
- Acronym / sponsor ID
- BernRehabReg / 2024-00480
- Keywords
- Rehabilitation, Prevention, Physical Function, Mental Function, Participation, Disabilities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 disease-specific comprehensive rehabilitation programmes at a tertiary referral center to improve the quality of care and formulate novel research questions.
Methods:
Consecutive patients with cancer, cardiovascular, musculoskeletal, or pulmonary diseases, referred for comprehensive rehabilitation to the Centre for Rehabilitation \& Sports Medicine (two locations - Berner Reha Centre and Inselspital) of the Insel Group, Bern, Switzerland, will be included. Patients will be counselled by trained advanced practice nurses, and type of delivery of the rehabilitation programme will be based on medical needs and patient preferences. Three-week inpatient programmes are performed at the Berner Reha Centre and Inselspital. Twelve-week outpatient programmes are performed at the Inselspital and delivered as centre-based, digitally-enhanced centre- and home-based, or home-based digital/tele rehabilitation.
Outcome assessments will be based on the framework of the International Classification of Functioning, Disability, and Health (ICF) of the World Health Organisation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer | – | Other: Comprehensive disease-specific rehabilitationAge 18+ years, indication for cancer rehabilitation |
| Patients with cardiovascular diseases | – | Other: Comprehensive disease-specific rehabilitationAge 18+ years, indication for cardiovascular rehabilitation |
| Patients with musculoskeletal diseases | – | Other: Comprehensive disease-specific rehabilitationAge 18+ years, indication for musculoskeletal rehabilitation |
| Patients with pulmonary diseases | – | Other: Comprehensive disease-specific rehabilitationAge 18+ years, indication for pulmonary rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic, non-communicable diseases participating in a comprehensive disease-specific rehabilitation program.
Key inclusion criteria (3 listed)
- Patients aged 18 years and older with a chronic non-communicable disease
- Signed general informed consent
- Referral to a comprehensive disease-specific rehabilitation program
Key exclusion criteria (1 listed)
- Refuted or missing general informed consent for further use of health-related data and samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive disease-specific rehabilitationParticipation 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. | Other | Patients with cancer, Patients with cardiovascular diseases, Patients with musculoskeletal diseases, Patients with pulmonary diseases |
Primary outcome
Short-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Time frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)
Stratified by type of delivery and cohort
Long-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Time frame: From discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) to one year follow-up
Stratified by type of delivery and cohort
20 secondary outcomes
Short- and long-term change (absolute and percentage) in muscle strength, measured by grip strength (kg)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 (%)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At rehabilitation discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and at one year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Website of the Centre for Rehabilitation \& Sports Medicine, Insel Group BernLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Wilhelm, MD principal investigator
Centre for Rehabilitation & Sports Medicine, Insel Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cardiovascular Diseases, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Wilhelm, MD (+41 31 632 8986, matthias.wilhelm@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m) (time frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.