HospitalismNCT03516032
Effect of Physiotherapy and Rehabilitation Program on Physical Activity Level in the Elderly Inpatient
A study testing exercises in people with Hospitalism, run by Hacettepe University.
Trial summary
In inpatient older adults, decrement in their mobility and loss in their physical activity are seen in time line between their hospitalization and discharge. The aim of our study was to investigate the effect of physiotherapy and rehabilitation program on physical activity, functional skills and quality of life in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalism
- What is being tested?
- exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 15 Dec 2016
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older
- Mini Mental State Examination score greater than 24;
- Stayed in the hospital at least 48 hours.
Who cannot join
- Angiina pectoris, acute myocarditis, myocardial infarction story in the last 3 months,
- Pulmonary embolism and deep vein thrombosis within the last 3 months,
- Active infection,
- Malignancy and terminal disease status,
- Fracture story in the lower and upper extremities in the last three months
- Severe hearing and visual loss.
About this study
In inpatient older adults, decrement in their mobility and loss in their physical activity are seen in time line between their hospitalization and discharge. The aim of our study was to investigate the effect of physiotherapy and rehabilitation program on physical activity, functional skills and quality of life in elderly inpatient. A total of 124 patients who were randomized as study and control group followed by Hacettepe University Faculty of Medicine Department of Internal Medicine, Division of Geriatric Medicine were included to the study. Thirty minutes physiotherapy and rehabilitation program was applied to the patients in the study group according to their functional levels. Geriatric patients in the control group did exercises by themselves. Demographic data, cognitive functions, muscle strength, presence of comorbidity, functional mobility, physical activity, daily living activities, fear of fall, quality of life and depression status were assessed of all cases. Activities of daily living and depression status was questioned again three months later. This study evaluated the efficacy and cost effectiveness of increasing physical activity in older people during inpatient rehabilitation. These results could assist in the development of evidenced-based rehabilitation programs for this population.
- Conditions
- Hospitalism
- Being tested
- exercises
- Keywords
- exercises therapy, rehabilitation, aged, inpatients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| walking exercises | Experimental | walking in the hospital corridor Receives: Behavioral: exercises |
| balance exercises | Experimental | heel rise exercises Receives: Behavioral: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEMMI-De Morton Mobility Scale
The De Morton Mobility Scale (DEMMI) was used to record the changes in mobility of the patients from admission to discharge. The score is between 0-100, and high scores indicate that mobility is better. Performance of a wide range of mobility tasks such as getting in and out of bed, standing from a chair and walking is observed and scored. The DEMMI has demonstrated reliability and validity in older adults
Measured: 5 DAYS
EQ5D-EQ-5D EuroQool Health Quality Assesment
For quality of life assessment, we used the EuroQol- 5 Dimension (EQ-5D). The EQ-5D describes health status according to five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels, namely, "no problems", "some problems" and "severe problems". Besides the five dimensions, the EQ-5D consists of a visual analogue scale (VAS-5D) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: 5 DAYS
PAIR-Physical Activity in Inpatient Rehabilitation Assessment
Patient mobility was assessed by Physical Activity in Inpatient Rehabilitation Assessment (PAIR). PAIR was developed to allow an estimation of physical activity levels in inpatients. PAIR was to provide a cost-saving and widely available tool which is easy to implement within the rehabilitation process. This scale is scored between 0 and 7; "0" indicates that the patient is only in bed to recover, and "7" indicates that the patient can walk to the outside of the hospital to recover
Measured: 5 DAYS
Secondary outcomes (2)
Katz Activities of Daily Living Scale
The basic activities of daily living were evaluated using Katz Activities of Daily Living (ADL) Scale. It includes six categories of activities: bathing, dressing, toilet needs, transfer, continence and feeding. Each item has three response options: dependent, partially dependent or independent. A score of 6 points on the scale shows dependence, a score between 7 and 12 shows partial dependence, and a score between 13 and 18 shows independence
Measured: 5 DAYS
GDS-Geriatric Depression Scale
Depression statues was measured using the Geriatric Depression Scale - Short Form (GDS-15) which was developed and validated for measurement of depressive symptoms among elderly people. This scale has been widely used as a screening tool for depressive disorders in older people, with valid and reliable psychometric measures.
Measured: 10 AND 90 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jan 2015
- Primary completion15 Sep 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HospitalismStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Karapınar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516032
- Sponsor's protocol ID
- 15/750
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Karapinar M, Kirdi N, Firat T. Effectiveness of supervised and functional level-based exercise program in elderly inpatients: Randomised controlled trial. Clin Rehabil. 2022 Dec;36(12):1623-1634. doi: 10.1177/02692155221116818. Epub 2022 Jul 25.
PubMed 35880264
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy and Rehabilitation Program on Physical Activity Level in the Elderly Inpatient
- ClinicalTrials.gov ID
- NCT03516032
- Acronym / sponsor ID
- 15/750
- Conditions
- Hospitalism
- Keywords
- exercises therapy, rehabilitation, aged, inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 4 May 2018 (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.
In inpatient older adults, decrement in their mobility and loss in their physical activity are seen in time line between their hospitalization and discharge. The aim of our study was to investigate the effect of physiotherapy and rehabilitation program on physical activity, functional skills and quality of life in elderly inpatient. A total of 124 patients who were randomized as study and control group followed by Hacettepe University Faculty of Medicine Department of Internal Medicine, Division of Geriatric Medicine were included to the study. Thirty minutes physiotherapy and rehabilitation program was applied to the patients in the study group according to their functional levels. Geriatric patients in the control group did exercises by themselves. Demographic data, cognitive functions, muscle strength, presence of comorbidity, functional mobility, physical activity, daily living activities, fear of fall, quality of life and depression status were assessed of all cases. Activities of daily living and depression status was questioned again three months later. This study evaluated the efficacy and cost effectiveness of increasing physical activity in older people during inpatient rehabilitation. These results could assist in the development of evidenced-based rehabilitation programs for this population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walking exercises | Experimental | Behavioral: exerciseswalking in the hospital corridor |
| balance exercises | Experimental | Behavioral: exercisesheel rise exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years or older
- Mini Mental State Examination score greater than 24;
- Stayed in the hospital at least 48 hours.
Key exclusion criteria (6 listed)
- Angiina pectoris, acute myocarditis, myocardial infarction story in the last 3 months,
- Pulmonary embolism and deep vein thrombosis within the last 3 months,
- Active infection,
- Malignancy and terminal disease status,
- Fracture story in the lower and upper extremities in the last three months
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 |
|---|---|---|
| exercises | Behavioural | balance exercises, walking exercises |
Primary outcome
DEMMI-De Morton Mobility Scale
Time frame: 5 DAYS
The De Morton Mobility Scale (DEMMI) was used to record the changes in mobility of the patients from admission to discharge. The score is between 0-100, and high scores indicate that mobility is better. Performance of a wide range of mobility tasks such as getting in and out of bed, standing from a chair and walking is observed and scored. The DEMMI has demonstrated reliability and validity in older adults
EQ5D-EQ-5D EuroQool Health Quality Assesment
Time frame: 5 DAYS
For quality of life assessment, we used the EuroQol- 5 Dimension (EQ-5D). The EQ-5D describes health status according to five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels, namely, "no problems", "some problems" and "severe problems". Besides the five dimensions, the EQ-5D consists of a visual analogue scale (VAS-5D) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
PAIR-Physical Activity in Inpatient Rehabilitation Assessment
Time frame: 5 DAYS
Patient mobility was assessed by Physical Activity in Inpatient Rehabilitation Assessment (PAIR). PAIR was developed to allow an estimation of physical activity levels in inpatients. PAIR was to provide a cost-saving and widely available tool which is easy to implement within the rehabilitation process. This scale is scored between 0 and 7; "0" indicates that the patient is only in bed to recover, and "7" indicates that the patient can walk to the outside of the hospital to recover
2 secondary outcomes
Katz Activities of Daily Living Scale
Time frame: 5 DAYS
GDS-Geriatric Depression Scale
Time frame: 10 AND 90 DAYS
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 4 May 2018.
- Derived from this study: PubMed 35880264Karapinar M, Kirdi N, Firat T. Effectiveness of supervised and functional level-based exercise program in elderly inpatients: Randomised controlled trial. Clin Rehabil. 2022 Dec;36(12):1623-1634. doi: 10.1177/02692155221116818. Epub 2022 Jul 25.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Hospitalism, run by Hacettepe University.
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 6 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
DEMMI-De Morton Mobility Scale (time frame: 5 DAYS). The study lists 3 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 NCT03516032, which also lists 1 linked publication.
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 4 May 2018.