ElderlyEarly Phase 1NCT00785746
Improving Balance in Frail Elderly
A Early Phase 1 study testing Core in people with Elderly and Frail, run by McGill University at 1 site in Canada.
Trial summary
The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch \& Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Core
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to Dec 2009
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elderly persons attending the geriatric day hospital at the royal victoria hospital
Who cannot join
- persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
- the individuals at high risk for falls
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University-Royal Victoria Hospital Site
Montreal, Quebec, H3A-1A1
About this study
Official title: Improving Balance in Frail Elderly: A Randomized Clinical Trial of Two Methods to Enhance Strength (Stretch and Strength Versus Core Strength)
The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch \& Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence.
Read the detailed description
Participants will be randomized to one of the two exercise groups, Core-Strength training group or the Stretch \& Strength group. The exercises will consist of 15-20 minute session for every day they attend the GDH. Measures will be made at admission, after 6 weeks of the program and at discharge if more than past 6 weeks.
- Being tested
- Core
- Keywords
- elderly, balance, core, strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreOther
We have devised a series of core strength training exercises that can be easily and safely performed under the supervision of trained staff. The exercises will be individualized depending on the participants' ability and health conditions. The majority, but not all, of exercises will be performed on or with exercise balls of different sizes and shapes, round for more advanced persons and oval for more frail persons.
| Study group | Role | What they receive |
|---|---|---|
| core | Experimental | strength training of the core muscles. Receives: Other: Core |
| stretch and strength | No intervention | This program consists of general stretching exercises and peripheral muscle strengthening exercises with a special emphasis on strengthening the upper extremity muscles because of their importance for ADL but not necessarily balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
Measured: baseline, 6 weeks, discharge
Secondary outcomes (5)
Functional walking capacity 6 minute walk test
Measured: baseline, 6 weeks, discharge
Gait speed
Measured: baseline, 6 weeks, discharge
Bridge Test
Measured: Baseline, 6 weeks, discharge
Activities-Specific Balance Confidence Scale (ABC Scale)
Measured: Baseline, 6 weeks, Discharge
International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI)
Measured: Baseline, 6 weeks, discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy E Mayo, PhD, Principal investigator, McGill University, Division of Clinical Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785746
- Sponsor's protocol ID
- SDR-06--010
- Status last verified
- Mar 2010
- First submitted
- 4 Nov 2008
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Balance in Frail Elderly: A Randomized Clinical Trial of Two Methods to Enhance Strength (Stretch and Strength Versus Core Strength)
- ClinicalTrials.gov ID
- NCT00785746
- Acronym / sponsor ID
- SDR-06--010
- Keywords
- elderly, balance, core, strength
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Nov 2008 (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.
The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch \& Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence.
Detailed description
Participants will be randomized to one of the two exercise groups, Core-Strength training group or the Stretch \& Strength group. The exercises will consist of 15-20 minute session for every day they attend the GDH. Measures will be made at admission, after 6 weeks of the program and at discharge if more than past 6 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core | Experimental | Other: Corestrength training of the core muscles. |
| stretch and strength | No intervention | –This program consists of general stretching exercises and peripheral muscle strengthening exercises with a special emphasis on strengthening the upper extremity muscles because of their importance for ADL but not necessarily balance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- elderly persons attending the geriatric day hospital at the royal victoria hospital
Key exclusion criteria (2 listed)
- persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
- the individuals at high risk for falls
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 |
|---|---|---|
| CoreWe have devised a series of core strength training exercises that can be easily and safely performed under the supervision of trained staff. The exercises will be individualized depending on the participants' ability and health conditions. The majority, but not all, of exercises will be performed on or with exercise balls of different sizes and shapes, round for more advanced persons and oval for more frail persons. | Other | core |
Primary outcome
Berg balance scale
Time frame: baseline, 6 weeks, discharge
5 secondary outcomes
Functional walking capacity 6 minute walk test
Time frame: baseline, 6 weeks, discharge
Gait speed
Time frame: baseline, 6 weeks, discharge
Bridge Test
Time frame: Baseline, 6 weeks, discharge
Activities-Specific Balance Confidence Scale (ABC Scale)
Time frame: Baseline, 6 weeks, Discharge
International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI)
Time frame: Baseline, 6 weeks, discharge
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 Feb 2013.
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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.
Nancy E Mayo, PhD principal investigator
McGill University, Division of Clinical Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Core in people with Elderly and Frail, run by McGill University at 1 site in Canada.
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 1 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 4 Feb 2013. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Berg balance scale (time frame: baseline, 6 weeks, discharge). 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 4 Feb 2013.