NCT06307210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 4, 2024

Last Update Submit

March 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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).

Other: inpatient rehabilitation

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).

Other: inpatient rehabilitation

Interventions

physiotherapy (strength and endurance training), occupational therapy and neuropsychological training

age group 75-84age group 85-99

Eligibility Criteria

Age75 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Valens

Valens, Canton of St. Gallen, CH-7317, Switzerland

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Motor ActivityMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Roman Gonzenbach, Dr.

    Kliniken Valens

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

January 1, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations