- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516032
Effect of Physiotherapy and Rehabilitation Program on Physical Activity Level in the Elderly Inpatient
April 23, 2018 updated by: Merve Karapınar, Hacettepe University
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 Overview
Study Type
Interventional
Enrollment (Actual)
323
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 65 years or older
- Mini Mental State Examination score greater than 24;
- Stayed in the hospital at least 48 hours.
Exclusion Criteria :
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: walking exercises
walking in the hospital corridor
|
|
Experimental: balance exercises
heel rise exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 DAYS
|
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).
|
5 DAYS
|
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
|
5 DAYS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Katz Activities of Daily Living Scale
Time Frame: 5 DAYS
|
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
|
5 DAYS
|
GDS-Geriatric Depression Scale
Time Frame: 10 AND 90 DAYS
|
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.
|
10 AND 90 DAYS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
September 15, 2016
Study Completion (Actual)
December 15, 2016
Study Registration Dates
First Submitted
April 4, 2018
First Submitted That Met QC Criteria
April 23, 2018
First Posted (Actual)
May 4, 2018
Study Record Updates
Last Update Posted (Actual)
May 4, 2018
Last Update Submitted That Met QC Criteria
April 23, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15/750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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