Accidental FallsNCT01830634
Lower-limb Strength and Flexibility Program on Prevention of Falls in the Community-dwelling Elderly
A study testing Theraband with strengthening and stretching exercise in people with Accidental Falls, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Theraband with strengthening and stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jul 2006
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- elder living in community
- age > 65 years old
Who cannot join
- no walking ability before fall
- conscious change or disease induce fall
- impaired cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strength and Flexibility Training With Elastic Band on Gait Pattern and Functional Ability in the Elderly
Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.
Read the detailed description
To estimate the effect of strength and flexibility training with elastic band on community-dwelling elderly gait, balance, and functional performance. All subjects received a home exercise program with low resistance elastic band training. All subjects were assessed for functional assessment, balance and gait analysis at initial and after training.
- Conditions
- Accidental Falls
- Being tested
- Theraband with strengthening and stretching exercise
- Keywords
- Community-dwelling elderly, Rehabilitation, Theraband, Strengthening and stretching exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraband with strengthening and stretching exerciseBehavioural
Using the theraband for strengthening and stretching the upper and lower extremity muscles.
All exercises were performed by using a Theraband in the following movements: shoulder elevating and abducting, horizontal and oblique direction, plantar flexion, dorsi-flexion, inversion and eversion of ankle, knee extension and hip abduction. The stretching exercises were focused on the hamstring muscle and heel cord. Each movement was held for 5 seconds. The participants were instructed to perform 5-10 repetitions of each movements twice per day.
| Study group | Role | What they receive |
|---|---|---|
| Theraband with strengthening and stretching exercise | Experimental | All subjects were received theraband exercises (strengthening and stretching), and then compare the measured outcomes between groups. Receives: Behavioral: Theraband with strengthening and stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized balance evaluation
computerized balance and gait evaluation by a posturography and gait analysis system
Measured: after 3 months intervention
Secondary outcomes (1)
improve in functional activity
functional reach and timed up-and-go test
Measured: after 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJun 2005
- Primary completionJan 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
- Investigators
- TaSen Wei, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830634
- Sponsor's protocol ID
- I050507
- Other IDs
- NSC-93-2314-B-371-002
- Status last verified
- Jan 2020
- First submitted
- 10 Apr 2013
- Last updated
- 31 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength and Flexibility Training With Elastic Band on Gait Pattern and Functional Ability in the Elderly
- ClinicalTrials.gov ID
- NCT01830634
- Acronym / sponsor ID
- I050507
- Conditions
- Accidental Falls
- Keywords
- Community-dwelling elderly, Rehabilitation, Theraband, Strengthening and stretching exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 12 Apr 2013 (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.
Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.
Detailed description
To estimate the effect of strength and flexibility training with elastic band on community-dwelling elderly gait, balance, and functional performance. All subjects received a home exercise program with low resistance elastic band training. All subjects were assessed for functional assessment, balance and gait analysis at initial and after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theraband with strengthening and stretching exercise | Experimental | Behavioral: Theraband with strengthening and stretching exerciseAll subjects were received theraband exercises (strengthening and stretching), and then compare the measured outcomes between groups. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elder living in community
- age > 65 years old
Key exclusion criteria (3 listed)
- no walking ability before fall
- conscious change or disease induce fall
- impaired cognition
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 |
|---|---|---|
| Theraband with strengthening and stretching exerciseUsing the theraband for strengthening and stretching the upper and lower extremity muscles. All exercises were performed by using a Theraband in the following movements: shoulder elevating and abducting, horizontal and oblique direction, plantar flexion, dorsi-flexion, inversion and eversion of ankle, knee extension and hip abduction. The stretching exercises were focused on the hamstring muscle and heel cord. Each movement was held for 5 seconds. The participants were instructed to perform 5-10 repetitions of each movements twice per day. | Behavioural | Theraband with strengthening and stretching exercise |
Primary outcome
Computerized balance evaluation
Time frame: after 3 months intervention
computerized balance and gait evaluation by a posturography and gait analysis system
1 secondary outcome
improve in functional activity
Time frame: after 3 months intervention
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 31 Jan 2020.
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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.
TaSen Wei principal investigator
Changhua Christian 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 Theraband with strengthening and stretching exercise in people with Accidental Falls, run by Changhua Christian Hospital at 1 site in Taiwan.
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 3 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 31 Jan 2020. 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 Taiwan. 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?
Computerized balance evaluation (time frame: after 3 months intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.