NCT03289091

Brief Summary

The aim of the study is to investigate the effects of two water based aerobic training programs on cardiorespiratory, neuromuscular and quality of life parameters in old women. Volunteer old women age range: 60-75 years old, will participate to this study, and will randomly divided into two groups: continuous aerobic training group and interval aerobic training group. Both group subjects will participate in two-week training sessions during 12 weeks. Independent of the group, participants will perform three water-based exercises: stationary running, frontal kick and cross-country skiing. The intensity of aerobic exercise will be based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise will increase in both groups. Before and after intervention, there will be evaluation of muscle quality, muscle thickness, peak oxygen uptake and oxygen uptake at ventilatory threshold, maximal isometric and dynamic strength of knee extensors, maximal and submaximal isometric eletromiografy (EMG) activity of vastus lateralis and rectus femoris, muscle endurance, performance in functional tests and assessment of the perception of quality of life. Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc test (α=0.05), including both protocol and intention to treat analyses (α=0,05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

September 18, 2017

Last Update Submit

January 13, 2019

Conditions

Keywords

aerobic trainingaquatic exerciseaging

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory Fitness evaluation change after 12 weeks

    We created a protocol on the treadmill to determine the peak oxygen uptake change(VO2peak), the first ventilatory threshold and the second ventilatory threshold. The protocol consists in 1-minute stages. The initial speed is 1.86 miles per hour. In each stage, the speed increases 0.3 miles per hour and every 2 stages, the treadmill inclination increases 1%. The test is interrupted when the subject indicates exhaustion. The respiratory gases will be collected through a portable gas analyzer (VO2000, MedGraphics, Ann Arbor, USA). The maximum value of VO2 , closed to exhaustion will be considered the VO2peak. The fist and the second ventilatory threshold will be determined by the ventilation versus intensity curve and confirmed by the O2 and Carbon dioxide ventilatory equivalents by two independent physiologists in a visual inspection.

    Testing of VO2peak change - Baseline and 12 week

Secondary Outcomes (6)

  • Quality of Life change after 12 weeks (Score)

    Baseline and 12 week

  • Maximal dynamic strength change after 12 weeks (kg)

    Baseline and 12 week

  • Maximal voluntary isometric contraction of knee extensors change after 12 weeks

    Baseline and 12 week

  • muscle thickness of knee extensors change after 12 weeks

    Baseline and 12 week

  • neuromuscular economy of vastus lateralis and rectus femoris change after 12 weeks

    Baseline and 12 week

  • +1 more secondary outcomes

Study Arms (2)

water-based continuous aerobic training

EXPERIMENTAL

Participants who will be randomized for the intervention in the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.

Behavioral: water-based continuous aerobic training

water-based interval aerobic training

EXPERIMENTAL

Participants who will be randomized for the intervention in the interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.

Behavioral: water-based interval aerobic training

Interventions

Participants who will be randomized for the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.

water-based continuous aerobic training

Participants who will be randomized for interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.

water-based interval aerobic training

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 six 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

Study Officials

  • Cristine Alberton, 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

September 18, 2017

First Posted

September 20, 2017

Study Start

September 18, 2017

Primary Completion

May 31, 2018

Study Completion

July 31, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations