NCT03513354

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 19, 2018

Last Update Submit

April 6, 2019

Conditions

Keywords

AgingPhysical activityMotor activity

Outcome Measures

Primary Outcomes (1)

  • 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

    T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)

Secondary Outcomes (2)

  • Motor Scale for the Elders

    T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)

  • questionnaire-Short Form 36 (SF-36)

    T0 -baseline, T6- six months (twice a week, with duration of 1 hour each session)

Study Arms (3)

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)

Other: Soil groupOther: 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)

Other: Soil groupOther: Pool group

Interventions

Exercises in soil.

Pool groupSoil group

Exercises in pool.

Pool groupSoil group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) minimum age of 60 years, (2) presenting cognitive conditions for replying to instruments, (3) accepting and signing the ICF.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marcelo Cardoso de Souza, PT,PhD

    Adjunct Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
blinded assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups (swimming pool, soil, control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PT, PhD

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

October 5, 2015

Primary Completion

May 5, 2016

Study Completion

July 5, 2016

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

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