- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06307210
Is Inpatient Rehabilitation Effective for Very Old Patients?
Clinical Effects of Inpatient Rehabilitation in Very Old Patients With Neurological, Musculoskeletal or Geriatric Disorders
The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.
The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.
Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve.
Study Overview
Status
Intervention / Treatment
Detailed Description
Inpatient rehabilitation has been shown to improve exercise capacity and quality of life in patients with neurological and musculoskeletal disorders.
Rehabilitation in Valens includes intensive strength and endurance training. Expectedly improvements in physical and mental performance measured by Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) is recognized after inpatient rehabilitation. But is this clinical effect in the same way represented in very old patients?
To the knowledge of the investigators only few studies evaluated changes after rehabilitation in patients with neurological and musculoskeletal disorders in very old patients.
Therefore, the primary goal of this study is to evaluate changes in physical and mental performance in patients with neurological and musculoskeletal disorders after inpatient rehabilitation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Saint Gallen
-
Valens, Saint Gallen, Switzerland, CH-7317
- Klinik Valens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- german speaking
- age >74
- patients with neurological and musculoskeletal disorders
Exclusion Criteria:
- age <75
- patients with pulmonological and internal disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
age group 75-84
Inpatient rehabilitation included physiotherapy (30-60 min, 5 times/week), strength and endurance training (30-45 min, 3-5 times/week), occupational therapy (30 min, 2-3 times/week), and neuropsychological training (30 min, 2 times/week).
|
physiotherapy (strength and endurance training), occupational therapy and neuropsychological training
|
age group 85-99
Inpatient rehabilitation included physiotherapy (30-60 min, 5 times/week), strength and endurance training (30-45 min, 3-5 times/week), occupational therapy (30 min, 2-3 times/week), and neuropsychological training (30 min, 2 times/week).
|
physiotherapy (strength and endurance training), occupational therapy and neuropsychological training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FIM
Time Frame: 2 years
|
Functional Independence Measurement; 18 categories, focusing on motor and cognitive function; each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence); interval scale
|
2 years
|
TUG
Time Frame: 2 years
|
Timed Up and Go Test; used to assess a person's mobility; It uses the time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees; the faster the better; interval scale
|
2 years
|
EQ-5D (Quality of life)
Time Frame: 2 years
|
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol; EQ-5D assesses health status in terms of five dimensions of health (mobility, self care, usual activities, pain and discomfort, anxiety and depression); EQ-5D is not an abbreviation and is the correct term to use when referring to the instrument; the higher the better; minimum 0, maximum 100; interval scale
|
2 years
|
PROMIS
Time Frame: 2 years
|
Patient Reported Outcomes Measurement Information System; assessing physical, mental, and social well-being from the patient perspective; we assessed physical health (5 items, 0-10) and mental health (2 items, 0-10); interval scale
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Roman Gonzenbach, Dr., Kliniken Valens
Publications and helpful links
General Publications
- Maritz R, Tennant A, Fellinghauer C, Stucki G, Prodinger B. The Functional Independence Measure 18-item version can be reported as a unidimensional interval-scaled metric: Internal construct validity revisited. J Rehabil Med. 2019 Mar 13;51(3):193-200. doi: 10.2340/16501977-2525.
- Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
- Fries JF, Witter J, Rose M, Cella D, Khanna D, Morgan-DeWitt E. Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function. J Rheumatol. 2014 Jan;41(1):153-8. doi: 10.3899/jrheum.130813. Epub 2013 Nov 15.
- Valet M, Lejeune T, Devis M, van Pesch V, El Sankari S, Stoquart G. Timed Up-and-Go and 2-Minute Walk Test in patients with multiple sclerosis with mild disability: reliability, responsiveness and link with perceived fatigue. Eur J Phys Rehabil Med. 2019 Aug;55(4):450-455. doi: 10.23736/S1973-9087.18.05366-2. Epub 2018 Oct 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- coreset_2020_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Diseases
-
Wake Forest University Health SciencesRecruitingMusculoskeletal InjuryUnited States
-
Wroclaw University of Health and Sport SciencesUniversity School of Physical Education, Krakow, PolandCompletedMusculoskeletal DisorderPoland
-
Cairo UniversityNot yet recruiting
-
Laval UniversityCompletedMusculoskeletal DisorderCanada
-
Laval UniversityCompleted
-
Istituto Ortopedico RizzoliIstituto Clinico Humanitas; Istituto Giannina Gaslini; Ospedale Pediatrico Bambino... and other collaboratorsNot yet recruitingMusculoskeletal Abnormalities | Musculoskeletal Disorder | Musculoskeletal DeformityItaly
-
Singapore General HospitalSengkang General Hospital; Servo DynamicsCompletedWork-related Musculoskeletal DisordersSingapore
-
Vanderbilt UniversityCompletedScapular and Cervical Neuromuscular Control Deficits in Musicians With and Without Playing Injuries.Playing Related Musculoskeletal DisordersUnited States
-
Sheba Medical CenterUnknownWork Related Musculoskeletal DisordersIsrael
-
Aalborg UniversityDagrofa Logistics A/SRecruitingWork-related Musculoskeletal DisordersDenmark
Clinical Trials on inpatient rehabilitation
-
Schön Klinik Berchtesgadener LandCompletedIdiopathic Pulmonary FibrosisGermany
-
Tan Tock Seng HospitalCompletedSubarachnoid Hemorrhage, SpontaneousSingapore
-
University of RostockCompleted
-
Jennifer Bogner, PhD, ABPPPatient-Centered Outcomes Research Institute; University of UtahCompleted
-
University College, LondonRoyal National Orthopaedic Hospital NHS TrustRecruitingSpinal Cord InjuriesUnited Kingdom
-
Peking University Third HospitalUnknown
-
Samsung Medical CenterCompletedStroke | Rehabilitation | Biomarker | BDNFKorea, Republic of
-
The Catholic University of KoreaUnknownOsteoarthritis, Knee | Arthroplasty | Rehabilitation
-
Vetrea Terveys OyCompleted
-
Centro de Reabilitacao do NorteAveiro UniversityRecruitingGuillain-Barré SyndromePortugal