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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06307210
Other study ID # coreset_2020_2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2023

Study information

Verified date March 2024
Source Klinik Valens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2270
Est. completion date January 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years to 100 Years
Eligibility Inclusion Criteria: - german speaking - age >74 - patients with neurological and musculoskeletal disorders Exclusion Criteria: - age <75 - patients with pulmonological and internal disorders

Study Design


Intervention

Other:
inpatient rehabilitation
physiotherapy (strength and endurance training), occupational therapy and neuropsychological training

Locations

Country Name City State
Switzerland Klinik Valens Valens Saint Gallen

Sponsors (1)

Lead Sponsor Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. do — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary FIM 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
Primary TUG 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
Primary EQ-5D (Quality of life) 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
Primary PROMIS 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
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