AgingNCT01768819
Multimodal Physical Activity for the Elderly
A study testing Physical Activity in people with Aging and Physical Activity, run by Universidade Federal de Sao Carlos.
Trial summary
Although some authors have observed favorable effects of group physical activity programs, others have reported that the individualized prescription of exercises may be jeopardized by programs that do not allow sufficient consideration of individual characteristics. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2009
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the Geriatric Revitalization Program for one year
- Be on the waiting list for the Geriatric Revitalization Program
Who cannot join
- Attend less than 75% of the physical activity program's activities
- Absent any of the three follow-up physical parameter evaluations
About this study
Official title: The Effects of an Elderly-specific Multimodal Physical Activity Program: a Controlled Clinical Trial
Although some authors have observed favorable effects of group physical activity programs, others have reported that the individualized prescription of exercises may be jeopardized by programs that do not allow sufficient consideration of individual characteristics. Therefore, we aim to verify the effects of an elderly-specific multimodal physical activity program on physical parameters after one year of intervention.
- Conditions
- Aging, Physical Activity
- Being tested
- Physical Activity
- Keywords
- aging, exercise, muscle strength, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The intervention consisted of elderly-specific physical activity program for one year. During this period a total of 123 physical activity sessions were carried out. Each session lasted 50 minutes and included stretching, aerobic endurance exercises, resistance exercises, activities involving coordination, agility and flexibility, respiratory exercises and relaxation exercises. The sessions took place three times a week, according to American College of Sports Medicine (ACSM) recommendations. Workloads were adjusted for each subject bimonthly according to their capacity. The sessions were standardized and carried out by previously trained physical educators.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Physical Activity Receives: Behavioral: Physical Activity |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
The one-leg stance test (OLST) was used to evaluate static balance. A point was marked at eye level on a board approximately one meter from the volunteer. Focusing on this point, the volunteer, with arms akimbo, lifted the leg of his or her choice by flexing the knee. The performance was timed with a chronometer (precision: 1ms) until either the individual lost balance or 30s was reached. The test was then carried out with the opposite leg and the series was repeated until three trials per leg had been performed. The mean time of the three trials was used for analysis.
Measured: one year
Secondary outcomes (6)
Aerobic Endurance
Aerobic endurance was measured using the one-mile test or the Rockport Walking Test, which consists of having subjects walk 1,609 meters quickly, but without running. The time spent performing the task and the final heart rate were measured.
Measured: one year
Dynamic Balance
A maximum-speed walking test (MSWT) was used to measure dynamic balance. A course 3.33 m long and 33.3 cm wide was marked on the floor with tape and, beginning from a standing position, the participant walked the entire course as fast as possible without running when the signal was given. Three trials were carried out; the chronometer (precision: 1ms) was started as soon as the subject's foot crossed the starting line. The mean time from the trials was used for analysis.
Measured: one year
Flexibility
A sit-and-reach test (SRT) with a modified Wells flexometer (precision: 1mm) was used to evaluate the flexibility of the trunk and upper limbs. The subjects sat on the floor with their soles flush against the lower edge of the device. Then, with their overlapped hands on the upper surface touching a sliding position marker, they pushed it forward along the scale while exhaling. The best of three trials was considered the result.
Measured: one year
Handgrip Strength
Handgrip Strength was measured with a Jamar® hydraulic hand dynamometer (Sammons Preston Roylan, Bolingbrook, IL, USA) featuring a grading scale of 0-100 Kgf (precision: 2 Kgf). The best of three trials with the dominant upper limb was selected for analysis.
Measured: one year
Body Mass Index
The weight and height were measured with a calibrated analogue scale with a stadiometer. The variable of weight was measured three times and the mean value considered. Such variables were used to calculate the BMI of the volunteers.
Measured: one year
Body weight
The weight was measured with a calibrated analogue scale with a stadiometer. The variable was measured three times and the mean value considered.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Rubens Rebelatto, Universidade Federal de Sao Carlos
- Investigators
- José Rubens Rebelatto, Principal investigator, Universidade Federal de Sao CarlosFrancisco Albuquerque-Sendín, Study director, Universidade de SalamancaAlessandra Paiva Castro, Study chair, Universidade Federal do Espírito SantoThais Rabiatti Aurichio, Study chair, Universidade Federal de Sao CarlosKarla Helena Coelho Vilaça, Study chair, Universidade Católica de BrasíliaVictor da Silva Aquino, Study chair, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768819
- Sponsor's protocol ID
- 01 - REVITA
- Status last verified
- Jan 2013
- First submitted
- 12 Jan 2013
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Elderly-specific Multimodal Physical Activity Program: a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01768819
- Acronym / sponsor ID
- 01 - REVITA
- Conditions
- Aging, Physical Activity
- Keywords
- aging, exercise, muscle strength, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Jan 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.
Although some authors have observed favorable effects of group physical activity programs, others have reported that the individualized prescription of exercises may be jeopardized by programs that do not allow sufficient consideration of individual characteristics. Therefore, we aim to verify the effects of an elderly-specific multimodal physical activity program on physical parameters after one year of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physical ActivityPhysical Activity |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participate in the Geriatric Revitalization Program for one year
- Be on the waiting list for the Geriatric Revitalization Program
Key exclusion criteria (2 listed)
- Attend less than 75% of the physical activity program's activities
- Absent any of the three follow-up physical parameter evaluations
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 |
|---|---|---|
| Physical ActivityThe intervention consisted of elderly-specific physical activity program for one year. During this period a total of 123 physical activity sessions were carried out. Each session lasted 50 minutes and included stretching, aerobic endurance exercises, resistance exercises, activities involving coordination, agility and flexibility, respiratory exercises and relaxation exercises. The sessions took place three times a week, according to American College of Sports Medicine (ACSM) recommendations. Workloads were adjusted for each subject bimonthly according to their capacity. The sessions were standardized and carried out by previously trained physical educators. | Behavioural | Intervention Group |
Primary outcome
Static Balance
Time frame: one year
The one-leg stance test (OLST) was used to evaluate static balance. A point was marked at eye level on a board approximately one meter from the volunteer. Focusing on this point, the volunteer, with arms akimbo, lifted the leg of his or her choice by flexing the knee. The performance was timed with a chronometer (precision: 1ms) until either the individual lost balance or 30s was reached. The test was then carried out with the opposite leg and the series was repeated until three trials per leg had been performed. The mean time of the three trials was used for analysis.
6 secondary outcomes
Aerobic Endurance
Time frame: one year
Dynamic Balance
Time frame: one year
Flexibility
Time frame: one year
Handgrip Strength
Time frame: one year
Body Mass Index
Time frame: one year
Body weight
Time frame: one year
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 23 Jan 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.
José Rubens Rebelatto principal investigator
Universidade Federal de Sao Carlos
Francisco Albuquerque-Sendín study director
Universidade de Salamanca
Alessandra Paiva Castro study chair
Universidade Federal do Espírito Santo
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Aging and Physical Activity, run by Universidade Federal de Sao Carlos.
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 23 Jan 2013. 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?
Static Balance (time frame: one year). 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 23 Jan 2013.