Impact of a Kinesiotherapy Program on Soil and Aquatic Environment on Motor Fitness and Quality of Life of Elders.

April 6, 2019 updated by: Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcelo Cardoso de Souza, PT,PhD, Adjunct Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2015

Primary Completion (ACTUAL)

May 5, 2016

Study Completion (ACTUAL)

July 5, 2016

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (ACTUAL)

May 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 6, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • UFRNelders

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there isn't a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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