- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702557
Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer
May 2, 2016 updated by: Aalborg University Hospital
Feasibility Study of Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer as a Supplement to Usual Supervised Physiotherapy Sessions
This feasibility study investigates if frail elderly and hospitalized patients are able to perform unsupervised elastic band exercises as a supplement to their usual supervised physiotherapy sessions and how much training they perform during their hospitalization.
It is also investigated how the frail elderly and the health personnel experiences the unsupervised elastic band exercises.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Region Denmark
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Aalborg, North Region Denmark, Denmark, 9000
- Aalborg University Hospital
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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:
- Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator
- Able to read and understand Danish
Exclusion Criteria:
- Frail elderly and hospitalized patients with a score of <5 measured by the Short Portable Mental Status Questionnaire
- Frail elderly and hospitalized patients where resistance training and physical activity is contraindicated (evaluated by a geriatrician and/or physiotherapist)
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
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Elastic Band Exercises
Unsupervised Elastic band exercises performed once a day until the patient is discharged from the hospital.
One exercise for the upper extremity (row exercise level 1-3) and one exercise for the lower extremity (knee extension level 1-3).
The two exercises are both performed as 3 sets of 10 repetitions.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total number of sets performed
Time Frame: From inclusion-discharge from hospital - up to 6 weeks
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From inclusion-discharge from hospital - up to 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total number of repetitions performed
Time Frame: From inclusion-discharge from hospital - up to 6 weeks
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From inclusion-discharge from hospital - up to 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention
Time Frame: From inclusion-discharge from hospital - up to 6 weeks
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The mean deviation is calculated as the difference between actual TUT and prescribed TUT (8 seconds).
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From inclusion-discharge from hospital - up to 6 weeks
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Difference in score of two tests: The 30-s chair stand and the de Morton Mobility Index (DEMMI)
Time Frame: From beginning of hospitalization to discharge from hospital - up to 6 weeks
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From beginning of hospitalization to discharge from hospital - up to 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jane Andreasen, ph.d. stud., Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital
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
February 1, 2016
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 3, 2016
First Posted (ESTIMATE)
March 8, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
May 3, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-42
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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