Age ProblemsPrePhysFallsNCT03019211
Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly
A study testing Exercise in people with Age Problems and Cognitive Impairment, run by University Ramon Llull at 1 site in Spain.
Trial summary
This is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Problems, Cognitive Impairment, Elderly
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Mar 2017
- 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
- Be institutionalized in a care center
- Participate voluntarily and sign the informed consent
- Have a punctuation of 2 or more in The Downton Fall Risk Index
Who cannot join
- Suffer from a condition that can be affected or hinder exercise
- Acute disease unresolved in 10 days
- Not controlled hypertension
- Contagious skin disorder
- Urinary or faecal incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study
This is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. The secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.
Read the detailed description
The participants will be randomized and divided into the hydrotherapy group or the control group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. The study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.
- Conditions
- Age Problems, Cognitive Impairment, Elderly, Postural Balance, Strength
- Being tested
- Exercise
- Keywords
- Physical Therapy Modalities, Accidental Fall, Elderly, Hydrotherapy, Nursing Home
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy | Experimental | Exercise performed in an aquatic environment. The participants will perform static/dynamic exercises (balance and resistance training) in an aquatic environment. Training volume and intensity we will increase systematically over 12 weeks. Receives: Other: Exercise |
| Control | Active comparator | The participants will perform exercises (balance and resistance training) like hydrotherapy group but out of the aquatic environment, during a 12 weeks training period (3sessions/week). Training volume and intensity we will increase systematically over 12 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Number of Falls at 3 months, 6 months and 9 months
Falls follow up
Measured: 3 months, 6 months, 9 months
Secondary outcomes (6)
Balance measured with Performance Oriented Mobility Assessment
Measured with Performance Oriented Mobility Assessment
Measured: 3 months, 6 months, 9 months
Pain measured with Visual Analogue Scale
Measured with Visual Analogue Scale
Measured: 3 months, 6 months, 9 months
Mobility measured with Timed Up & Go Test
Measured with Timed Up \& Go Test
Measured: 3 months, 6 months, 9 months
Daily living activities measured with Barthel Test
Measured with Barthel Test
Measured: 3 months, 6 months, 9 months
Muscle strength measured with Five Sit to Stand test and Handgrip Test
Measured with Five Sit to Stand test and Handgrip Test
Measured: 3 months, 6 months, 9 months
Intervention Perception measured with Qualitative interview
Qualitative interview
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas Mayores Les Corts, Residencial Augusta Park
- Responsible party
- Sponsor
- Investigators
- Mercè Sitjà Rabert, PhD, PT, Principal investigator, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019211
- Sponsor's protocol ID
- PrePhysFalls
- Acronym
- PrePhysFalls
- Status last verified
- Sep 2016
- First submitted
- 8 Jan 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT03019211
- Acronym / sponsor ID
- PrePhysFalls / PrePhysFalls
- Conditions
- Age Problems, Cognitive Impairment, Elderly, Postural Balance, Strength
- Keywords
- Physical Therapy Modalities, Accidental Fall, Elderly, Hydrotherapy, Nursing Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Collaborators
- Sanitas Mayores Les Corts, Residencial Augusta Park
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Jan 2017 (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 is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. The secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.
Detailed description
The participants will be randomized and divided into the hydrotherapy group or the control group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. The study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy | Experimental | Other: ExerciseExercise performed in an aquatic environment. The participants will perform static/dynamic exercises (balance and resistance training) in an aquatic environment. Training volume and intensity we will increase systematically over 12 weeks. |
| Control | Active comparator | Other: ExerciseThe participants will perform exercises (balance and resistance training) like hydrotherapy group but out of the aquatic environment, during a 12 weeks training period (3sessions/week). Training volume and intensity we will increase systematically over 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Be institutionalized in a care center
- Participate voluntarily and sign the informed consent
- Have a punctuation of 2 or more in The Downton Fall Risk Index
Key exclusion criteria (5 listed)
- Suffer from a condition that can be affected or hinder exercise
- Acute disease unresolved in 10 days
- Not controlled hypertension
- Contagious skin disorder
- Urinary or faecal incontinence
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 |
|---|---|---|
| Exercise | Other | Control, Hydrotherapy |
Primary outcome
Change from baseline Number of Falls at 3 months, 6 months and 9 months
Time frame: 3 months, 6 months, 9 months
Falls follow up
6 secondary outcomes
Balance measured with Performance Oriented Mobility Assessment
Time frame: 3 months, 6 months, 9 months
Pain measured with Visual Analogue Scale
Time frame: 3 months, 6 months, 9 months
Mobility measured with Timed Up & Go Test
Time frame: 3 months, 6 months, 9 months
Daily living activities measured with Barthel Test
Time frame: 3 months, 6 months, 9 months
Muscle strength measured with Five Sit to Stand test and Handgrip Test
Time frame: 3 months, 6 months, 9 months
Intervention Perception measured with Qualitative interview
Time frame: 3 months
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 5 May 2017.
- Individual participant dataSharing planned: No
Related trials for Age Problems
Recruiting
A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Performance at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems
Cognition, Cognitive Performance
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruiting
Effects of an SMS-Based Parenting Intervention on Anxiety Symptoms in Preschool Children
Problematic Screen Use in Preschool Children, Anxiety Symptoms in Preschool Children
Active, not recruiting
Brain Health Virtual Reality Study
Aging, Aging Problems
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
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.
Mercè Sitjà Rabert, PhD, PT principal investigator
University Ramon Llull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Age Problems and Cognitive Impairment, run by University Ramon Llull at 1 site in Spain.
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 3 inclusion and 5 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 5 May 2017. 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 Spain. 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?
Change from baseline Number of Falls at 3 months, 6 months and 9 months (time frame: 3 months, 6 months, 9 months). 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 5 May 2017.