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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03403478
Other study ID # 79609117.0.0000.5188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date October 31, 2018

Study information

Verified date July 2019
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Elderly (60 years and over)

- Able to practice physical exercise in water

- Able to answer all questionnaires

- Non-smoker

Exclusion Criteria:

- Morbid obese

- Those who not complete all data collection procedures

Study Design


Intervention

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

Locations

Country Name City State
Brazil Bruno Teixeira Barbosa Joao Pessoa Paraíba

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Paraíba University Center of Joao Pessoa - UNIPE

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM). Entire day (an average of 24 hours).
Primary 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 Self-reported sleep quality Pittsburgh Sleep Quality Index Approximately 15 minutes
Secondary 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. Approximately 5 minutes
Secondary 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. Approximately 15 minutes
Secondary 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. Approximately 5 minutes
Secondary Functional Capacity AAPHERD test battery Approximately 35 minutes
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