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CompletedNCT03403478Updated Jul 5, 2019

Effects of Aquatic Exercise on Post-exercise Hypotension

An interventional study of LICE and MICE in Hypertension, Aging and Obesity, sponsored by Federal University of Paraíba. Completed at 1 site in Brazil. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Aging
  • Obesity

Keywords

  • Hemodynamics
  • Aquatic exercise
  • Elderly
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Morbid obese
  • Those who not complete all data collection procedures
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • No intervention
    Control group

    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.

  • Experimental
    LICE

    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

  • Experimental
    MICE

    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

  • Experimental
    HIIE

    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

  • Experimental
    Aquatic exercise training

    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

  • OtherLICE

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

  • OtherMICE

    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.

  • OtherHIIE

    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.

  • OtherAquatic exercise training

    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.

05

What researchers measure

Primary outcomes

  1. Blood pressure

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

    Time frame: Entire day (an average of 24 hours).

  2. Blood pressure

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

    Time frame: Up to 1 hour post-exercise session

Secondary outcomes

  1. Self-reported sleep quality

    Pittsburgh Sleep Quality Index

    Time frame: Approximately 15 minutes

  2. Depressive symptoms (Mental disorders)

    Geriatric depressive symptoms (GDS-15) is a validated questionnaire which will be used in order to evaluate depressive symptoms in elderly.

    Time frame: Approximately 5 minutes

  3. Self-reported quality of life

    Quality of life will be assessed by the WHOQOL-OLD questionnaire and it consists of 24 items on the likert scale attributed to 6 facets: 1) Sensory functioning, 2) Autonomy, 3) Past, present and future activities, 4) Social participation, 5) Death and dying, and 6) Intimacy. Each facet is composed of 4 items, so for each facet the score can range from 4 to 20. For this evaluation, the higher the score, the higher the quality of life.

    Time frame: Approximately 15 minutes

  4. Level of physical activity (BAECKE modified to elderly)

    The Habitual Physical Activity Questionnaire originated in 1982 by Baecke and colleagues (BAECKE; BUREMA, FRIJTERS, 1982) and was adapted for the elderly and validated later (VORORRIPS et al., 1991) and recently translated into Portuguese (SIMÕES, 2009). It is applied in the form of an interview, and has as reference the last 12 months being divided into 3 sections (1 - Domestic physical activities, 2 - Sporting activities and 3 - Activities in free time). From the scores attributed to each response provided by the elderly, scores equivalent to each section cited above are established. It is suggested that 3 cutoff points be created for the classification of the elderly regarding the level of physical activity (low, moderate and high) based on terciles.

    Time frame: Approximately 5 minutes

  5. Functional Capacity

    AAPHERD test battery

    Time frame: Approximately 35 minutes

06

Study locations

1 site
  • Bruno Teixeira Barbosa
    Joao Pessoa, Paraíba 58051420, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03403478
Lead sponsor
Federal University of Paraíba
Collaborators
University Center of Joao Pessoa - UNIPE
Responsible party
Bruno Teixeira Barbosa (Assistant Professor, Federal University of Paraíba) — Principal investigator
First posted
Jan 18, 2018
Start date
Mar 1, 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Jul 5, 2019

Study contacts

Bruno T Barbosa, Master
principal investigator · University Center of Joao Pessoa - UNIPE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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