NCT03210597

Brief Summary

The objective of the present study was to compare the neuromuscular, cardiorespiratory and metabolic effects of 12 weeks of aerobic training, strength training and combined training in the aquatic environment in women with MS. For this purpose, 51 postmenopausal, sedentary and MS women were randomly divided into three intervention groups: hydro-aerobic (HA, n = 18, 63.77 ± 5.03 years), hydro-power (HF, n = 16, 61.01 ± 4.93 years) and hydro-combined (HC; n = 17; 60.52 ± 6.91). A subsample participated in eight weeks without physical exercise to characterize a control period. The three intervention groups performed two weekly sessions of 60 minutes for 12 weeks. Before and after the training period, blood tests, muscle strength tests, cardiorespiratory evaluation, functional tests and a questionnaire were performed. For statistical analysis, the Generalized Estimates Equations (GEE) model was used, using the "group" and the "time" as factors. The Bonferroni post hoc was used to locate the differences and the significance index adopted was α = 0.05.

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 Aug 2016

Typical duration 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

August 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

June 22, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

water-base exercise

Outcome Measures

Primary Outcomes (1)

  • Systolic and diastolic blood pressure

    mmHg

    12 weeks

Secondary Outcomes (8)

  • Strength tests: Maximum dynamic muscle strength

    12 weeks

  • EMG test

    12 weeks

  • Time Up and go test

    12 weeks

  • Sit and Stand test

    12 weeks

  • Triglyceride levels

    12 weeks

  • +3 more secondary outcomes

Study Arms (3)

hydro-aerobic

EXPERIMENTAL

Water aerobics exercise

Other: Exercise

hydro-power

EXPERIMENTAL

Resistance water exercise

Other: Exercise

hydro-combined

EXPERIMENTAL

Water aerobics and resistance water exercise

Other: Exercise

Interventions

The subjects performed training in aquatic environment

hydro-aerobichydro-combinedhydro-power

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal;
  • Sedentary;
  • Presented at least three positive components within the five possible to characterize the metabolic syndrome.

You may not qualify if:

  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luiz F. Martins Kruel

    Federal Universty of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant: During the training period the subjects were not informed about the training modality they were performing and also were not informed about the modalities of the other subjects, only they were informed that hydrogymnastic sessions would be performed. Outcomes assessor:The team evaluating the outcomes was blinded, not receiving information about the intervention received by the subjects participating in the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 22, 2017

First Posted

July 7, 2017

Study Start

August 1, 2016

Primary Completion

December 28, 2016

Study Completion

October 10, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share