NCT03403478

Brief Summary

This is a randomized controlled trial. The present study involves an acute and chronic intervention, which is a water-based exercise (one session: to acute intervention; 12-weeks of aquatic exercise program: to chronic intervention). The sample will be composed by elderly enrolled in university extension program titled "Hidroginastica na Terceira Idade" (Hydrogymnastics in aging). It will be evaluated the effects of water-based exercise on hemodynamics, self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity. The investigators hypothesized that an acute water-based exercise under different intensities promotes hemodynamics changes in elderly. In addition, the investigators hypothesized that 12-weeks of aquatic exercise may lead improvements in self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity in elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable hypertension

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

January 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

January 7, 2018

Last Update Submit

July 1, 2019

Conditions

Keywords

HemodynamicsAquatic exerciseElderly

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).

    Entire day (an average of 24 hours).

  • Blood pressure

    The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).

    Up to 1 hour post-exercise session

Secondary Outcomes (5)

  • Self-reported sleep quality

    Approximately 15 minutes

  • Depressive symptoms (Mental disorders)

    Approximately 5 minutes

  • Self-reported quality of life

    Approximately 15 minutes

  • Level of physical activity (BAECKE modified to elderly)

    Approximately 5 minutes

  • Functional Capacity

    Approximately 35 minutes

Study Arms (5)

Control group

NO INTERVENTION

The volunteers will be instructed to remain in an orthostatic position immersed in water up to the imaginary line of the xiphoid process for 45 minutes without performing jerky body movements.

LICE

EXPERIMENTAL

The light-intensity continuou exercise (LICE) session comprises a 45-minute of guide walking into the pool at 55-60% of maximum heart rate (HRmax). The HR will be checked every 2 minutes during the whole session.

Other: LICE

MICE

EXPERIMENTAL

The moderate-intensity continuous exercise (MICE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (30 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 30 minutes and will be performed by 3 sets of 5 exercises lasting 2 minutes each one at 70-75% HRmax. For all phases, HR will be measured every 2 minutes during the whole session.

Other: MICE

HIIE

EXPERIMENTAL

The high-intensity intervaled exercise (HIIE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (15 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 15 minutes and will be performed by 2 sets of 5 exercises lasting 30 seconds to each exercise combined with 1 minute of active recovery. The exercise moment will be performed at 80-85% HRmax and the 1-minute active recovery at 55-60% HRmax. For both warm-up and cool down, HR will be measured every 2 minutes. For main part, HR will be measured at the end of each 30-seconds from exercise.

Other: HIIE

Aquatic exercise training

EXPERIMENTAL

The participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day.

Other: Aquatic exercise training

Interventions

LICEOTHER

No specific exercise will be performed. The participant will walk into the pool accompanied with a researcher for 45 minutes.

LICE
MICEOTHER

The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs. Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running.

MICE
HIIEOTHER

The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs. Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running.

HIIE

The sessions of the aquatic exercise training will be divided into 3 phases: warm-up (10 minutes), main part (40 minutes) and cool down. In order to increase intensity to aquatic exercise, the training program will carried out as follows: From week 1 to 4 the instructors will use a 128 bpm musics in both warm-up and cool down. In main part, will be used a 130 bmp musics. From week 5 to 8 the instructors will use a 130 bpm musics in both warm-up and cool down. In main part, will be used a 132 bmp musics. From week 9 to 12 the instructors will use a 132 bpm musics in both warm-up and cool down. In main part, will be used a 135 bmp musics.

Aquatic exercise training

Eligibility Criteria

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

You may qualify if:

  • Elderly (60 years and over)
  • Able to practice physical exercise in water
  • Able to answer all questionnaires
  • Non-smoker

You may not qualify if:

  • Morbid obese
  • Those who not complete all data collection procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruno Teixeira Barbosa

João Pessoa, Paraíba, 58051420, Brazil

Location

MeSH Terms

Conditions

HypertensionObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno T Barbosa, Master

    University Center of Joao Pessoa - UNIPE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To acute session, the participant will not be informed about what aquatic exercise session (light-, moderate-, high-intensity or control) intensity will be performed.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 18, 2018

Study Start

March 1, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations