Clinical trial NCT06307210: Is Inpatient Rehabilitation Effective for Very Old Patients?
Official title: Clinical Effects of Inpatient Rehabilitation in Very Old Patients With Neurological, Musculoskeletal or Geriatric Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Activity, Motor
Elderly Patients
Musculoskeletal Diseases
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 2270
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects were German-speaking and over 74 years old referred to the Rehabilitation Centre Valens in Switzerland for inpatient rehabilitation.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* german speaking
* age \>74
* patients with neurological and musculoskeletal disorders

Exclusion Criteria:

* age \<75
* patients with pulmonological and internal disorders

Primary outcomes:
measure: FIM
timeFrame: 2 years
measure: TUG
timeFrame: 2 years
measure: EQ-5D (Quality of life)
timeFrame: 2 years
measure: PROMIS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Klinik Valens
state: Saint Gallen
Study officials:
affiliation: Kliniken Valens
name: Roman Gonzenbach, Dr.
role: STUDY_DIRECTOR
References:
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. doi: 10.2340/16501977-2525.
citation: 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.
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.
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 Aug;55(4):450-455. doi: 10.23736/S1973-9087.18.05366-2. Epub 2018 Oct 4.