Frail ElderlyNCT02702557
Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer
A study testing Elastic Band Exercises in people with Frail Elderly, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Elastic Band Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to May 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
- Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator
- Able to read and understand Danish
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Frail Elderly
- Being tested
- Elastic Band Exercises
- Keywords
- Frail Elderly, Elastic Band Exercises, Unsupervised Exercises, Monitoring Technology, Bandcizer, Adherence, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Band ExercisesOther
Also called Bandcizer
| Study group | Role | What they receive |
|---|---|---|
| Elastic Band Exercises | Other | 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. Receives: Other: Elastic Band Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of sets performed
Measured: From inclusion-discharge from hospital - up to 6 weeks
Secondary outcomes (1)
The total number of repetitions performed
Measured: From inclusion-discharge from hospital - up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionMay 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 Frail ElderlyStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Amager Hospital, Hvidovre University Hospital, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jane Andreasen, ph.d. stud., Principal investigator, Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702557
- Sponsor's protocol ID
- 2016-42
- Status last verified
- May 2016
- First submitted
- 29 Feb 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rathleff CR, Bandholm T, Spaich EG, Jorgensen M, Andreasen J. Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology-a feasibility trial with an embedded qualitative study. Pilot Feasibility Stud. 2017 Nov 13;3:56. doi: 10.1186/s40814-017-0202-3. eCollection 2017.
PubMed 29158914
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02702557
- Acronym / sponsor ID
- 2016-42
- Conditions
- Frail Elderly
- Keywords
- Frail Elderly, Elastic Band Exercises, Unsupervised Exercises, Monitoring Technology, Bandcizer, Adherence, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University, Amager Hospital, Hvidovre University Hospital, University of Copenhagen
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elastic Band Exercises | Other | Other: Elastic Band ExercisesUnsupervised 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator
- Able to read and understand Danish
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Elastic Band ExercisesAlso: Bandcizer | Other | Elastic Band Exercises |
Primary outcome
Total number of sets performed
Time frame: From inclusion-discharge from hospital - up to 6 weeks
1 secondary outcome
The total number of repetitions performed
Time frame: From inclusion-discharge from hospital - up to 6 weeks
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 3 May 2016.
- Derived from this study: PubMed 29158914Rathleff CR, Bandholm T, Spaich EG, Jorgensen M, Andreasen J. Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology-a feasibility trial with an embedded qualitative study. Pilot Feasibility Stud. 2017 Nov 13;3:56. doi: 10.1186/s40814-017-0202-3. eCollection 2017.
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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.
Jane Andreasen, ph.d. stud. principal investigator
Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band Exercises in people with Frail Elderly, run by Aalborg University Hospital at 1 site in Denmark.
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 2 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 3 May 2016. 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 Denmark. 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?
Total number of sets performed (time frame: From inclusion-discharge from hospital - up to 6 weeks). 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 NCT02702557, 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 3 May 2016.