Activity, MotorNCT06307210
Is Inpatient Rehabilitation Effective for Very Old Patients?
An observational study of Activity, Motor and Elderly Patients, run by Klinik Valens at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 75 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor, Elderly Patients, Musculoskeletal Diseases
- What is being tested?
- inpatient rehabilitation
- How many people
- 2,270 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Eligible subjects were German-speaking and over 74 years old referred to the Rehabilitation Centre Valens in Switzerland for inpatient rehabilitation.
Who may be able to join
- german speaking
- age >74
- patients with neurological and musculoskeletal disorders
Who cannot join
- age <75
- patients with pulmonological and internal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Activity, Motor, Elderly Patients, Musculoskeletal Diseases
- Being tested
- inpatient rehabilitation
- Medical subject headings
- Motor Activity, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient rehabilitationOther
physiotherapy (strength and endurance training), occupational therapy and neuropsychological training
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: inpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Schallert, Klinik Valens
- Investigators
- Roman Gonzenbach, Dr., Study director, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307210
- Sponsor's protocol ID
- coreset_2020_2022
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet discussed
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.
PubMed 30843597Devlin 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.
PubMed 28194657Fries 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.
PubMed 24241485Valet 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.
PubMed 30311490
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Inpatient Rehabilitation in Very Old Patients With Neurological, Musculoskeletal or Geriatric Disorders
- ClinicalTrials.gov ID
- NCT06307210
- Acronym / sponsor ID
- coreset_2020_2022
- Conditions
- Activity, Motor, Elderly Patients, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,270 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| age group 75-84 | – | Other: inpatient rehabilitationInpatient 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). |
| age group 85-99 | – | Other: inpatient rehabilitationInpatient 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). |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Eligible subjects were German-speaking and over 74 years old referred to the Rehabilitation Centre Valens in Switzerland for inpatient rehabilitation.
Key inclusion criteria (3 listed)
- german speaking
- age >74
- patients with neurological and musculoskeletal disorders
Key exclusion criteria (2 listed)
- age <75
- patients with pulmonological and internal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inpatient rehabilitationphysiotherapy (strength and endurance training), occupational therapy and neuropsychological training | Other | age group 75-84, age group 85-99 |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 30843597Maritz 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.
- Results publication: PubMed 28194657Devlin 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.
- Results publication: PubMed 24241485Fries 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.
- Results publication: PubMed 30311490Valet 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.
- Individual participant dataSharing planned: Undecided. not yet discussed
Related trials for Activity, Motor
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Gonzenbach, Dr. study director
Kliniken Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Activity, Motor and Elderly Patients, run by Klinik Valens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIM (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307210, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.