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Effect of Different Volumes of Training of Pilates Exercises on Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03791502
Recruitment Status : Completed
First Posted : January 2, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mônica Batista Duarte Caetano, University of Brasilia

Brief Summary:
It will be an experimental study conducted with elderly of both sexes, these will be divided randomly into three groups and the intervention will happen twice a week, for 60 minutes, for 12 weeks. The aim of the study is to compare the effect of different volumes of Pilates exercise training on muscle strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung function in the elderly community. The investigators believe that Pilates exercises will have beneficial effects for the elderly, but the hypothesis is that the group that performs a greater volume of Pilates exercise training will have a greater improvement in the investigated outcomes than the group with the lowest volume.

Condition or disease Intervention/treatment Phase
Aging Exercise Movement Techniques Other: Pilates Method Exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into three groups, two intervention groups and one group will be the control. The randomization process will be done by a person who does not participate in the survey, at random.org, and concealment of the allocation will occur using opaque and sealed envelopes.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Different Volumes of Training of Pilates Exercises on Muscle Strength, Postural Balance, Flexibility, Functional Autonomy, Depressive Symptoms and Pulmonary Function on Elderly
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : October 2, 2019
Actual Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilates Method Exercises - lower volume
The prescription will consist of 18 exercises, performed in a single series of seven to 10 repetitions, 60 seconds rest between exercises. Each week the exercises will be changed and the same exercise can only be repeated every three weeks. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises, but without modifying the repetitions. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.
Other: Pilates Method Exercises
Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.

Experimental: Pilates Method Exercises - higher volume
The participants will conduct a Pilates exercise program based on the recommendations of the American College Medicine of Sports. The prescription will consist of 12 exercises, performed in three sets of seven to ten repetitions and 60s of rest between sets. Every four weeks the exercises will be changed. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.
Other: Pilates Method Exercises
Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.

No Intervention: Group control
The subjects allocated in the control group will remain with their usual activities, and after the reevaluation will be offered the intervention that presents the greater size of effect.



Primary Outcome Measures :
  1. Change in muscle strength of lower limbs [ Time Frame: 12 weeks ]
    The Biofeedback System will be used for the practice of resistance exercises with elastic overload (E-lastic®). E-lastic® will measure maximal isometric voluntary contraction of the knee flexor and extensor muscles, flexors, extensors, adductors and hip abductors before and after the intervention. For the acquisition of force signals, a load cell is used to provide an electrical signal proportional to the force that deforms the equipment. The participants will perform 3 repetitions, maintaining the contraction for 5 seconds, with 60 seconds of recovery and the highest value will be recorded.

  2. change in muscle strength and resistance of lower limbs [ Time Frame: 12 weeks ]
    The 30-second chair stand test (30-s CST) will be used. It consists of getting up and sitting on a chair as many times as possible within 30 seconds. A seat with backrest and without armrest (with a seat height of 45 cm) is used. Initially, participants remain seated and are instructed to look forward after command "1, 2, 3, will" they raise with their arms crossed on their chest. The evaluator will explain and demonstrate the test and the participant will do once for familiarization. You will be given a rest of 2 minutes to start the test.

  3. Change in palmar grip strength [ Time Frame: 12 weeks ]
    Will be measured using the Saehan® hydraulic palmar gripper dynamometer, the position recommended by the American Society of Hand Therapists (ASHT) will be adopted: sitting comfortably positioned with shoulder lightly bent, elbow bent at 90 °, forearm in neutral position and, finally, the position of the handle may vary from 0 ° to 30 ° of extension. It will be used to record the maximum and average manual grip strength of three measurements and the values will be compared with the reference values.

  4. Change in static postural balance [ Time Frame: 12 weeks ]
    The static balance will be evaluated by measuring the time each participant can maintain in three progressively more difficult positions: semi-tandem, tandem and unipedal support. In all positions the individuals must be with their hands on their waist, the total time to stay in each position is 30 seconds and it will have 3 attempts in each position and the best time will be recorded. The evaluator will demonstrate the test once.

  5. Change in dynamic postural balance (TUG) [ Time Frame: 12 weeks ]
    To evaluate the dynamic balance, the Timed Up and Go Test (TUG) will be used. The TUG starts with the participant sitting in the chair, in the "go" command, he gets up from the chair, walks 3 meters at a comfortable pace, turns around, goes back to the chair and sits down. It will be demonstrated once and then it will do a repeat for familiarization.

  6. Change in dynamic postural balance (Step) [ Time Frame: 12 weeks ]
    To evaluate the dynamic balance, the Step Test will be used. The Alternative Step Test the participant is asked to make eight beats of foot, alternating between right and left, on a step in front of him with a height of 18 cm. Time will be timed and used in the analyzes. The test should be performed in 10 seconds.

  7. Change in flexibility [ Time Frame: 12 weeks ]
    To evaluate the flexibility of the hamstring muscles will be used the Sit and Go Test, using the Wells bench, participants will remain without footwear, sitting with knees extended, shoulders flexed, elbows extended and hands overlapped. Participants should perform trunk flexion at the front, perform a forced expiration, and move the seat ladder as far as possible, this procedure will be performed three times and immediately noted by the evaluator, with the best.


Secondary Outcome Measures :
  1. Functional Autonomy [ Time Frame: 12 weeks ]
    The functional autonomy of the upper limbs will be evaluated by the dressing test and a t-shirt. Initially the evaluator will explain the test and the volunteer will do a brief training with two replicates. The execution time is marked in seconds and the shorter the execution time, the better the result. The subject must make two attempts, where the best performance attempt will be recorded.

  2. Depressive symptoms [ Time Frame: 12 weeks ]
    The Geriatric Depression Scale will be used for the evaluation of depressive symptoms in the elderly and screening for depression among older people. Geriatric depression scale will be presented as an interview and the questions have a yes / no format to be easy to understand. The short version consists of 15 questions, one point is given for each "yes" answer and the number of points is added to provide a single score. The score ranges from 0 to 15 and a score of zero to five is considered normal, six to ten indicates mild depression and 11 to 15 suggests severe depression.

  3. Change in respiratory muscle strength [ Time Frame: 12 weeks ]
    Respiratory muscle strength will be measured by assessing maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in cmH2O. These measures represent the strength of the inspiratory and expiratory muscles respectively. It will be using the manometer of the brand Globalmed® MVD300, calibrated, patient seated at 90º, a nasal clip and a nozzle connected to the equipment will be placed. In order to assess MIP, a maximum expiration up to the residual volume and, in the sequence, a maximum sustained forced inspiration will be required. And to assess PEmax inspiration will be required up to the total lung capacity and, subsequently, a forced maximum expiration up to the residual volume. Three reproducible measurements will be made, with variation less than 10% and the values found will be compared with those predicted.

  4. Change in pulmonary function (FVC) [ Time Frame: 12 weeks ]
    Pulmonary function will also be evaluated by spirometry. The test measures forced vital capacity (FVC) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations

  5. Change in pulmonary function (FEV1) [ Time Frame: 12 weeks ]
    Pulmonary function will also be evaluated by spirometry. The test measures the forced expiratory volume in the first second (FEV1) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations

  6. Change in pulmonary function (FEV1 / FVC ratio) [ Time Frame: 12 weeks ]
    Pulmonary function will also be evaluated by spirometry. The test measures the FEV1 / FVC ratio. A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To present cognitive aptitude according to the Mental State Mini-Exam (MMSE)
  • Independent walking, without the use of auxiliary walking devices;
  • Not participating in other physical intervention research;
  • Not having undergone physiotherapeutic treatment and not having participated in a structured physical activity in the previous month;
  • Do not present neurological diseases, history of fractures or recent surgeries and serious cardiorespiratory diseases.

Exclusion Criteria:

  • Failure to attend all stages of evaluation;
  • They did not complete 80% of the intervention;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791502


Locations
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Brazil
Mônica Batista Duarte Caetano
Goiânia, Goiás, Brazil, 74343530
Sponsors and Collaborators
University of Brasilia
Investigators
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Principal Investigator: Mônica D Caetano University of Brasilia
  Study Documents (Full-Text)

Documents provided by Mônica Batista Duarte Caetano, University of Brasilia:
Publications:

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Responsible Party: Mônica Batista Duarte Caetano, Postgraduate Student of the Post-graduation Program in Rehabilitation Sciences da University de Brasilia, University of Brasilia
ClinicalTrials.gov Identifier: NCT03791502    
Other Study ID Numbers: MP2018
First Posted: January 2, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mônica Batista Duarte Caetano, University of Brasilia:
Exercise Movement Techniques
Elderly
Muscular Strength
Postural Balance
Flexibility
Pilates