Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06516172

The Bern Rehab Registry

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Cardiovascular Diseases Lung Diseases Musculoskeletal Diseases Neoplasms Pulmonary Disease Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berner Reha Centre, Centre for Rehabilitation & Sports Medicine, Insel Group, Heiligenschwendi, Canton of Bern, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    Stratified by type of delivery and cohort

  2. 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

    Stratified by type of delivery and cohort

  3. 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

    In patients participating in inpatient rehabilitation, stratified by cohort

  4. 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

    Stratified by type of delivery and cohort

  5. 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

    Stratified by type of delivery and cohort

  6. 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

    In patients with heart failure, stratified by type of delivery

  7. 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

    In patients with heart disease participating in outpatient cardiac rehabilitation or telerehabilitation

  8. 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

    In patients with heart disease participating in inpatient cardiac rehabilitation

  9. 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

    In patients with pulmonary disease, stratified by type of delivery

  10. 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

    In patients with cancer, stratified by type of delivery

  11. 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

    Stratified by type of delivery and cohort

  12. 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

    Stratified by type of delivery and cohort

  13. 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

    Composite outcome, stratified by type of delivery and cohort

  14. 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

    Stratified by type of delivery and cohort

  15. 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

    Stratified by type of delivery and cohort

  16. 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

    Stratified by type of delivery and cohort

  17. 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

    Stratified by type of delivery and cohort

  18. 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

    Composite outcome, stratified by type of delivery and cohort

  19. 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

    Stratified by type of delivery and cohort

  20. 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

    Stratified by type of delivery and cohort

Other outcomes

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

    Time frame: 12 months

    Stratified by type cohort

  2. 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)

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

    Stratified by type of delivery and cohort

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias Wilhelm, MD

CONTACT

[email protected]

+41 31 632 8986

Prisca Eser, PhD

CONTACT

[email protected]

+41 31 632 4398

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

The Bern Rehab Registry - a Prospective Cohort Study in Patients With Chronic Non-communicable Diseases Participating in a Comprehensive Rehabilitation Programme

Acronym: BernRehabReg

Important dates

Study start
2020
Primary completion
2029
Study completion
2030
First posted
Jul 23, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.