- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513354
Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders.
Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders. A Randomized Controlled Trial.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (1) minimum age of 60 years, (2) presenting cognitive conditions for replying to instruments, (3) accepting and signing the ICF.
Exclusion Criteria:
- (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control group
The control group did not perform any of the interventions.
|
|
|
EXPERIMENTAL: Soil 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)
|
Exercises in soil.
Exercises in pool.
|
|
EXPERIMENTAL: 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)
|
Exercises in soil.
Exercises in pool.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Scale for the Elders
Time Frame: T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
|
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)
|
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)
|
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"
|
T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marcelo Cardoso de Souza, PT,PhD, Adjunct Professor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UFRNelders
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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