ElderlyNCT03513354
Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders.
A study testing Soil group and Pool group in people with Elderly, run by Universidade Federal do Rio Grande do Norte.
Trial summary
Introduction: Neuromotor losses are those that most affect the functionality of the elderly person. One of the preventive measures is the habit of practicing exercises regularly. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Soil group and Pool group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2015to 5 Jul 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) minimum age of 60 years, (2) presenting cognitive conditions for replying to instruments, (3) accepting and signing the ICF.
Who cannot join
- (1) presenting cognitive state suggestive of deficit according to the Mini-Mental State Examination (MMSE), (2) presenting skin infections, urinary or fecal incontinence that contraindicates the entry in the swimming pool, (3) sensory, mental and neurological changes that prevent the understanding and realization of motor testing, (4) functional limitations and/or presence of important sequels (physical disability, amputation of a member), (5) those who presented some pathology during intervention which prevented continuing the exercises.
About this study
Official title: Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders. A Randomized Controlled Trial.
Introduction: Neuromotor losses are those that most affect the functionality of the elderly person. One of the preventive measures is the habit of practicing exercises regularly. Objective: To evaluate the motor fitness and the quality of life of elders before and after intervention, performed on soil and aquatic environment. Methodology: This was a randomized controlled trial, with blind evaluator and total sample of 38 elders, divided into three groups: control (n=15), soil (n=15), swimming pool (n=8). The following research instruments were used: socio-demographic data and health conditions, International Physical Activity Questionnaire (IPAQ), Mini-Mental State Examination (MMSE), Motor Scale for the Elders (MSE) and Quality of Life Questionnaire Short Form-36 (SF-36). The elders were submitted to a physiotherapeutic program during six months. Data were analyzed by statistical software Statistical Package for Social Science (SPSS 20.0). Results: When comparing motor fitness averages after intervention by study group, the soil group had higher mean values for the fine motor (p=0.021), body scheme (p=0.006), space organization (p=0.011) and general motor fitness (p=0.004) than the control group. In the quality of life, when comparing intra-group means, both intervention groups had higher averages in the general health aspect domain (p=0.001 and p=0.005 for the soil and swimming pool groups, respectively). Conclusion: This study showed that the soil group presented significantly higher means than the control group after the intervention, and the intra-group quality of life improved in both the soil as the swimming pool.
Read the detailed description
The recruitment occurred in the period from October to November 2015 and the intervention was carried out from January to July 2016.
Trained evaluators applied the research instruments, the data were collected in the Faculty of Health Sciences of Trairi (FACISA). Other volunteers were responsible for conducting the intervention, other than those that evaluated.
A physiotherapeutic exercise program was applied during a period of six months, twice a week, with duration of 1 hour each session, assessing the elders before and after six months of intervention.
The same exercise program was performed, both on soil as in the swimming pool, following these steps: (1) measurement of vital signs at the beginning and at the end of the intervention: Systemic Arterial Pressure (SAP), Heart Rate (HR), Oxygen Saturation (Sp02), (2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes).
The resisted exercise was conducted based on one maximum repetition (1MR), being used a 60% load, increasing the number of repetitions (2 repetitions) every month, starting with 2 sets of 8 repetitions in the first month, 2x10, 2x12, 2x14, 2x16 in the second, third, fourth and fifth month, respectively, ending with 2 x 18 with 60% of 1MR load and rest time of one minute between each series using dumbbells and shin guards for the resistance. In the pool, 2kg of water was used, maintaining the same series and repetitions in soil. The control group did not perform any of the interventions.
- Conditions
- Elderly
- Being tested
- Soil group, Pool group
- Keywords
- Aging, Physical activity, Motor 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.
Soil groupOther
Exercises in soil.
Pool groupOther
Exercises in pool.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group did not perform any of the interventions. |
| Soil group | Experimental | (2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes) Receives: Other: Soil group; Other: Pool group |
| Pool group | Experimental | (2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes) Receives: Other: Soil group; Other: Pool group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
Mini-Mental State Examination - with scores ranging from zero to 30 [15]. The classification of cognitive function from the MMSE score occurred as follows: 30 to 26 points - preserved cognitive functions; 26 the 24 points - change is not suggestive of deficit and 23 points or less - suggestive of cognitive deficit. The cutoff points for educational levels were the following: 18 - illiterate, 21 - elementary education and 24 - high school or higher education
Measured: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
Secondary outcomes (2)
Motor Scale for the Elders
Motor Scale for the Elders - validated for the Brazilian elderly population, which allows evaluating specific areas of human kinetics: fine kinetics, global kinetics, balance, body scheme, space organization and time organization [17]. Each test presents different difficulty degrees, which increases insofar as the levels advance. The results of the scores are classified into levels, as follows: far superior (130 or more), superior (120-129), high normal (110-119), average normal (90-109), low normal (80-89), low (70-79), and far low (<70)
Measured: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
questionnaire-Short Form 36 (SF-36)
questionnaire-Short Form 36 (SF-36) -questionnaire with 36 items, divided into eight areas: functional capacity, physical aspects, pain, health general state, vitality, social aspects, emotional aspects, mental health and one question of comparative evaluation between current health conditions and the health conditions from the previous year [18]. Each question had a score, which were later transformed into a 0 to 100 scale, where zero corresponds to the "the worst health state" and 100, to "the best health state"
Measured: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start5 Oct 2015
- Primary completion5 May 2016
- Study completion5 Jul 2016
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups (swimming pool, soil, control group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte
- Investigators
- Marcelo Cardoso de Souza, PT,PhD, Principal investigator, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513354
- Sponsor's protocol ID
- UFRNelders
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there isn't a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03513354
- Acronym / sponsor ID
- UFRNelders
- Conditions
- Elderly
- Keywords
- Aging, Physical activity, Motor activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 Jul 2016 (actual)
- First posted
- 1 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.
Introduction: Neuromotor losses are those that most affect the functionality of the elderly person. One of the preventive measures is the habit of practicing exercises regularly. Objective: To evaluate the motor fitness and the quality of life of elders before and after intervention, performed on soil and aquatic environment. Methodology: This was a randomized controlled trial, with blind evaluator and total sample of 38 elders, divided into three groups: control (n=15), soil (n=15), swimming pool (n=8). The following research instruments were used: socio-demographic data and health conditions, International Physical Activity Questionnaire (IPAQ), Mini-Mental State Examination (MMSE), Motor Scale for the Elders (MSE) and Quality of Life Questionnaire Short Form-36 (SF-36). The elders were submitted to a physiotherapeutic program during six months. Data were analyzed by statistical software Statistical Package for Social Science (SPSS 20.0). Results: When comparing motor fitness averages after intervention by study group, the soil group had higher mean values for the fine motor (p=0.021), body scheme (p=0.006), space organization (p=0.011) and general motor fitness (p=0.004) than the control group. In the quality of life, when comparing intra-group means, both intervention groups had higher averages in the general health aspect domain (p=0.001 and p=0.005 for the soil and swimming pool groups, respectively). Conclusion: This study showed that the soil group presented significantly higher means than the control group after the intervention, and the intra-group quality of life improved in both the soil as the swimming pool.
Detailed description
The recruitment occurred in the period from October to November 2015 and the intervention was carried out from January to July 2016.
Trained evaluators applied the research instruments, the data were collected in the Faculty of Health Sciences of Trairi (FACISA). Other volunteers were responsible for conducting the intervention, other than those that evaluated.
A physiotherapeutic exercise program was applied during a period of six months, twice a week, with duration of 1 hour each session, assessing the elders before and after six months of intervention.
The same exercise program was performed, both on soil as in the swimming pool, following these steps: (1) measurement of vital signs at the beginning and at the end of the intervention: Systemic Arterial Pressure (SAP), Heart Rate (HR), Oxygen Saturation (Sp02), (2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes).
The resisted exercise was conducted based on one maximum repetition (1MR), being used a 60% load, increasing the number of repetitions (2 repetitions) every month, starting with 2 sets of 8 repetitions in the first month, 2x10, 2x12, 2x14, 2x16 in the second, third, fourth and fifth month, respectively, ending with 2 x 18 with 60% of 1MR load and rest time of one minute between each series using dumbbells and shin guards for the resistance. In the pool, 2kg of water was used, maintaining the same series and repetitions in soil. The control group did not perform any of the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 3 groups (swimming pool, soil, control group)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group did not perform any of the interventions. |
| Soil group | Experimental | Other: Soil group, Other: Pool group(2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes) |
| Pool group | Experimental | Other: Soil group, Other: Pool group(2) Stretching from the lateral flexors of the cervical spine, elbow flexors and extensors, trunk lateral flexors, flexors and extensors of hip with support of 30 seconds (1x30), (3) aerobic workout through front and lateral gait walking for 20 minutes, (4) resisted exercise for upper limbs (anterior, middle and posterior deltoid, biceps, triceps) and to the lower limbs (abductors, flexors and extensors of hip and flexors and extensors knee, calf), using dumbbells and shin guards for the resistance (20 minutes), (5) balance and proprioception training through front and backward walking on mattresses, march in a straight line with one foot in front of the other, one-feet support orthostatism, touching some points marked on the ground with the toe (15 minutes) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) minimum age of 60 years, (2) presenting cognitive conditions for replying to instruments, (3) accepting and signing the ICF.
Key exclusion criteria (1 listed)
- (1) presenting cognitive state suggestive of deficit according to the Mini-Mental State Examination (MMSE), (2) presenting skin infections, urinary or fecal incontinence that contraindicates the entry in the swimming pool, (3) sensory, mental and neurological changes that prevent the understanding and realization of motor testing, (4) functional limitations and/or presence of important sequels (physical disability, amputation of a member), (5) those who presented some pathology during intervention which prevented continuing the exercises.
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 |
|---|---|---|
| Soil groupExercises in soil. | Other | Pool group, Soil group |
| Pool groupExercises in pool. | Other | Pool group, Soil group |
Primary outcome
Mini-Mental State Examination
Time frame: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
Mini-Mental State Examination - with scores ranging from zero to 30 [15]. The classification of cognitive function from the MMSE score occurred as follows: 30 to 26 points - preserved cognitive functions; 26 the 24 points - change is not suggestive of deficit and 23 points or less - suggestive of cognitive deficit. The cutoff points for educational levels were the following: 18 - illiterate, 21 - elementary education and 24 - high school or higher education
2 secondary outcomes
Motor Scale for the Elders
Time frame: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
questionnaire-Short Form 36 (SF-36)
Time frame: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
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 9 Apr 2019.
- Individual participant dataSharing planned: No. there isn't a plan to make individual participant data (IPD) available to other researchers.
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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.
Marcelo Cardoso de Souza, PT,PhD principal investigator
Adjunct Professor
Questions about this trial
What is this clinical trial studying?
A study testing Soil group and Pool group in people with Elderly, run by Universidade Federal do Rio Grande do Norte.
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 1 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 9 Apr 2019. 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?
Mini-Mental State Examination (time frame: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)). 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 9 Apr 2019.