NCT03892278

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

March 5, 2019

Last Update Submit

January 17, 2020

Conditions

Keywords

combined trainingaerobic trainingaquatic exercisesaging

Outcome Measures

Primary Outcomes (4)

  • Maximal dynamic strength change after eight and sixteen weeks (Kg)

    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.

    Baseline, 8 week and 16 week

  • Maximal voluntary isometric contraction of knee extensors change after eight and sixteen weeks

    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.

    Baseline, 8 week and 16 week

  • Maximum muscular activity of vastus lateralis and rectus femoris change after eight and sixteen weeks

    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.

    Baseline, 8 week and 16 week

  • Muscle thickness and echo intensity of knee extensors change after eight and sixteen weeks

    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.

    Baseline, 8 week and 16 week

Secondary Outcomes (16)

  • Dynamic muscular resistance change after sixteen weeks

    Baseline and 16 week

  • Cardiorespiratory Fitness evaluation change after sixteen weeks

    Baseline and 16 week

  • Cardiorespiratory Fitness evaluation change after sixteen weeks

    Baseline and 16 week

  • Cardiorespiratory Fitness evaluation change after sixteen weeks

    Baseline and 16 week

  • Heart rate change after sixteen weeks

    Baseline and 16 week

  • +11 more secondary outcomes

Study Arms (3)

Aerobic training

EXPERIMENTAL

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

Aerobic and combined training

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Aerobic 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).

Aerobic and combined training
Control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (2)

  • Hafele MS, Alberton CL, Hafele V, Schaun GZ, Nunes GN, Calonego C, Castro TF, Andrade LS, Pinto SS. Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. Res Q Exerc Sport. 2023 Mar;94(1):24-34. doi: 10.1080/02701367.2021.1935433. Epub 2022 Mar 16.

  • Hafele MS, Alberton CL, Schaun GZ, Hafele V, Nunes GN, Andrade LS, Pinto SS. Quality of life responses after combined and aerobic water-based training programs in older women: a randomized clinical trial (ACTIVE Study). Aging Clin Exp Res. 2022 May;34(5):1123-1131. doi: 10.1007/s40520-021-02040-5. Epub 2022 Jan 13.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Stephanie Pinto, Phd

    UFPel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in physical education school

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 27, 2019

Study Start

January 21, 2019

Primary Completion

December 20, 2019

Study Completion

December 15, 2020

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations