Balance; DistortedNCT03521752
Influence of an Exercise Program in the Elderly Balance
A study testing Specific Exercise Program in people with Balance; Distorted, run by Cooperativa de Ensino Superior, Politécnico e Universitário.
Trial summary
This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Specific Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2015to 22 Jun 2015
- 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
- Age ≥ 65 years
- institutionalized elderly
- Both genders
- Mini-Mental ≥19 pontos
- Protocol attendance ≥ 90%
Who cannot join
- Cardiovascular diseases
- Contraindication to physical exercise
- Medication (anxiolytics, antidepressants)
- Vestibular disorders
- Previous physiotherapy of 6 months to the present study
- Neurological and neuromuscular diseases
- Use of gaiters
- Another type of physical exercise during the study
About this study
Official title: Influence of a Specific Exercise Program in the Institutionalized Elderly Balance
This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly.
It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.
- Conditions
- Balance; Distorted
- Being tested
- Specific Exercise Program
- Keywords
- BALANCE, INSTITUTIONALIZED ELDERLY PEOPLE, THERAPEUTIC EXERCISE, FUNCTIONAL CAPACITY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Exercise ProgramOther
4 weeks of exercise classes, 2 to 3 times a week for a total of 10 sessions. Classes last approximately 40 minutes. The sessions included balance training, motor strength, endurance and flexibility. The training sessions were divided into warm-up, main activity and finally relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Performed a specific program exercises (resistance training, balance, coordination and flexibility) during 4 weeks. Receives: Other: Specific Exercise Program |
| Control | No intervention | The control group wasn't subjected to any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Performance Oriented Mobility Assessment (POMA) This scale measures the static and dynamic balance, through the evaluation of some daily activities.
This scale's scores are between 9 to 28 points, when 9 means hig risk of falling, and 28 means low risk of falling.
It was used before and after the intervention.
Measured: 4 weeks
Secondary outcomes (1)
Functional capacity
Timed up and Go (TUG) This scale measures the mobility and locomotor performance, through the timing of an activity (lift from a chair, walk 3 meters, change direction and return to starting position).
The cut-off points of the scale are divided into fully independent elderly (<10 seconds), independent elderly (10-19 seconds), and elderly people with difficulties in the tasks of daily living (20-29 seconds).
It was evaluated before and after the intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start4 May 2015
- Primary completion14 May 2015
- Study completion22 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e Universitário
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cátia Filipa Flores Guimarães, Cooperativa de Ensino Superior, Politécnico e Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521752
- Sponsor's protocol ID
- 1CESPU
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Specific Exercise Program in the Institutionalized Elderly Balance
- ClinicalTrials.gov ID
- NCT03521752
- Acronym / sponsor ID
- 1CESPU
- Conditions
- Balance; Distorted
- Keywords
- BALANCE, INSTITUTIONALIZED ELDERLY PEOPLE, THERAPEUTIC EXERCISE, FUNCTIONAL CAPACITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e UniversitárioUniversity, hospital or other
- Study start
- 4 May 2015 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 22 Jun 2015 (actual)
- First posted
- 11 May 2018 (actual)
- 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 study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly.
It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Specific Exercise ProgramPerformed a specific program exercises (resistance training, balance, coordination and flexibility) during 4 weeks. |
| Control | No intervention | –The control group wasn't subjected to any intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- institutionalized elderly
- Both genders
- Mini-Mental ≥19 pontos
- Protocol attendance ≥ 90%
Key exclusion criteria (8 listed)
- Cardiovascular diseases
- Contraindication to physical exercise
- Medication (anxiolytics, antidepressants)
- Vestibular disorders
- Previous physiotherapy of 6 months to the present study
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 |
|---|---|---|
| Specific Exercise Program4 weeks of exercise classes, 2 to 3 times a week for a total of 10 sessions. Classes last approximately 40 minutes. The sessions included balance training, motor strength, endurance and flexibility. The training sessions were divided into warm-up, main activity and finally relaxation. | Other | Experimental |
Primary outcome
Balance
Time frame: 4 weeks
Performance Oriented Mobility Assessment (POMA) This scale measures the static and dynamic balance, through the evaluation of some daily activities. This scale's scores are between 9 to 28 points, when 9 means hig risk of falling, and 28 means low risk of falling. It was used before and after the intervention.
1 secondary outcome
Functional capacity
Time frame: 4 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 16 May 2018.
Related trials for Balance; Distorted
Recruiting
Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
Neuropathy, Ataxia
Recruiting
Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
Multiple Sclerosis, Mobility Limitation
Recruiting
Effect of Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Chronic Ankle Instability
Cognitive Training, Functional Core Stability Training
Recruiting
Effects of Otago and Gaze Stabilization Exercises on Balance, Gait and QOL in Elderly Stroke Patients
Balance; Distorted, Gait, Hemiplegic
Enrolling by invitationObservational study
Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy
Postural Stability, Balance; Distorted
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Exercise Program in people with Balance; Distorted, run by Cooperativa de Ensino Superior, Politécnico e Universitário.
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 5 inclusion and 8 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Balance (time frame: 4 weeks). 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 16 May 2018.