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Effects of Water-based Aerobic and Combined Training in Elderly Woman (ACTIVE)

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ClinicalTrials.gov Identifier: NCT03892278
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie Santana Pinto, Federal University of Pelotas

Brief Summary:

Purpose: Investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.

Materials and methods: Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): water-based aerobic training (WBA) and control group (CG). After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC). The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session. The WBA training will be performed in the percentages of heart rate corresponding to the anaerobic threshold and the resistance training sets will be performed at maximal effort. Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17). The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).


Condition or disease Intervention/treatment Phase
Elderly Women Behavioral: Water-based aerobic training Behavioral: Water-based aerobic and combined training Behavioral: Control group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of 16 Weeks of Different Water-based Training Programs on Neuromuscular, Cardiorespiratory, Functional Capacity, Quality of Life and Cognitive Function Variables in Elderly Woman: a Randomized Clinical Trial
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Aerobic training
Participants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.
Behavioral: Water-based aerobic training
Participants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.

Experimental: Aerobic and combined training
Participants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16).
Behavioral: Water-based aerobic and combined training
Participants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16).

Active Comparator: Control group
The control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort.
Behavioral: Control group
The control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort.




Primary Outcome Measures :
  1. Maximal dynamic strength change after eight and sixteen weeks (Kg) [ Time Frame: Baseline, 8 week and 16 week ]
    Maximal dynamic strenght will be evaluate sing the one-repetition maximum test (1RM) on the bilateral knee extensors and free-weight barbell bilateral elbow flexors. The 1RM value will be consider as the maximal load that could be exerted at the concentric phase for a given exercise. Subjects will be familiar with al procedures in a session one week prior to the test day. Performance time for each contraction (concentric and eccentric) will be controlled by an electronic metronome.

  2. Maximal voluntary isometric contraction of knee extensors change after eight and sixteen weeks [ Time Frame: Baseline, 8 week and 16 week ]
    The curve of maximum isometric muscle strength of knee extension will be collected at the same time as the eletromiography signal by dynamometer (MIOTEC, Porto Alegre, Brasil) connected to the electromyography. The subjects will receive instruction to exert maximal strength possible as fast as was possible when extending both knees. The subjects will have three attempts at obtaining the maximal voluntary contraction (MVC) of the knee extensors, each lasting 5 s.

  3. Maximum muscular activity of vastus lateralis and rectus femoris change after eight and sixteen weeks [ Time Frame: Baseline, 8 week and 16 week ]
    The maximal neuromuscular activity of agonist knee extensors muscles will be evaluate using surface electromyography (RMS values) on the vastus lateralis (VL) and rectus femoris (RF). Electrodes were positioned on the muscular belly in a bipolar configuration in parallel with the orientation of the muscle fibers, according to SENIAM project (www.seniam.org). To ensure the same electrode position in subsequent tests, the right thigh of each subject will be map out for the position of the electrode moles and small angiomas by marking on transparent paper.

  4. Muscle thickness and echo intensity of knee extensors change after eight and sixteen weeks [ Time Frame: Baseline, 8 week and 16 week ]
    Echo intensity and muscle thickness measures will be performed using ultrasound equipment (TOSHIBA-Tosbee/SSA-240A, Japan), with evaluation image in B-mode. Cross-sectional images will be obtained in the muscles of rights lower limbs: vastus lateralis, vastus medialis, vastus intermedius and rectus femoris. The images will be made in the vastus lateralis, vastus intermedius and rectus femoris (midway between the edge of the lateral condyle of the femur and the tip of the greater trochanter) and in the vastus medialis (20% between the edge of the lateral condyle of the femur and the tip of the greater trochanter). To ensure the same probe position in subsequent tests, the right thigh of each subject will be map out for the position of the transductor and small angiomas by marking on transparent paper.


Secondary Outcome Measures :
  1. Dynamic muscular resistance change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Dynamic muscular resistance will be evaluate during the bilateral knee extensors and free-weight barbell bilateral elbow flexors exercises using a load corresponding to 60% of the 1RM.

  2. Cardiorespiratory Fitness evaluation change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Protocol on the treadmill to determine the peak oxygen uptake change (VO2peak).

  3. Cardiorespiratory Fitness evaluation change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Protocol on the treadmill to determine the first ventilatory threshold.

  4. Cardiorespiratory Fitness evaluation change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Protocol on the treadmill to determine the second ventilatory threshold.

  5. Heart rate change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Heart rate resting.

  6. Blood pressure change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Resting blood pressure

  7. Functional capacity change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Tests: 30-Second Chair Stand.

  8. Functional capacity change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Test: 8-Foot Up-and-Go.

  9. Functional capacity change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Test: Chair sit-and-reach.

  10. Functional capacity change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Test: 6-Minute Walk

  11. Functional capacity change after sixteen weeks [ Time Frame: Baseline and 16 week ]
    Test: 8-Foot Up-and-Go during the dual-task condition

  12. Quality of Life change after sixteen weeks (Score) [ Time Frame: Baseline and 16 week ]
    World Health Organization Quality of Life - WHOQOL-bref. Scores range from 0 to 100 (0 being the lowest score possible). Higher values represent a better outcome.

  13. Quality of Life change after sixteen weeks (Score) [ Time Frame: Baseline and 16 week ]
    World Health Organization Quality of Life - WHOQOL-old. Scores can range from 24 to 120. Higher values represent better quality of life.

  14. Cognitive function change after sixteen weeks (Score) [ Time Frame: Baseline and 16 week ]
    Mini mental state examination The questionnaire consists of two parts, one that covers orientation, memory and attention (21 points). The second discusses specific skills such as naming and understanding (9 points). The scores range from 0 to 30. Higher values represent a better outcome.

  15. Occurrence of low back pain change after sixteen weeks (%) [ Time Frame: Baseline and 16 week ]
    Semi-structured questionnaire Percentage of occurrence of low back pain (higher values represent higher occurrence of low back pain).

  16. Intensity of low back pain change after sixteen weeks (Scale) [ Time Frame: Baseline and 16 week ]
    Semi-structured questionnaire. Numerical pain scale 0 (no pain) to 10 (worst pain possible).



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteer elderly women, aged between 60-75 years old who were not participating on any regular training program in the last four months

Exclusion Criteria:

  • Cardiovascular disease (except hypertension controlled by medication);
  • Physical impairments for exercise diagnosed through anamnesis;

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): NCT03892278


Contacts
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Contact: Mariana Silva, Ms 555332732752 ext 555332732752 marianaesef@hotmail.com

Locations
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Brazil
Universidade Federal de Pelotas Recruiting
Pelotas, Rio Grande Do Sul, Brazil, 96055-630
Contact: Mariana Silva    5553981538402    marianaesef@hotmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Investigators
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Principal Investigator: Stephanie Pinto, Phd UFPel

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Responsible Party: Stephanie Santana Pinto, Professor in physical education school, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03892278     History of Changes
Other Study ID Numbers: ACTIVE
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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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 Stephanie Santana Pinto, Federal University of Pelotas:
combined training
aerobic training
aquatic exercises
aging