High-intensity Training for Improving Physical Performance of Aged Women (AHIITATE)

March 4, 2019 updated by: María Carrasco Poyatos, Universidad de Almeria

Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women

This study evaluates the adaptations on the functional capacity and cardiovascular in elderly after a physical activity program circuit training. The participants were divided into three groups: Circuit training based on high-intensity interval training group (HIICT), Circuit training at moderate intensity group (MICT) and Control group (CG).

Study Overview

Detailed Description

Three groups of participants (circuit training based on high-intensity interval training, circuit training at moderate intensity and not training group) will enter the study. The intervention will consist of a physical exercise program in day centers.

Intensity progression will be encouraged according to the rate of perceived exertion. Progression of exertion will be "very hard", "extremely hard" and "maximal exertion" for HIT group, and "light", "somewhat hard" and "hard" for group. Assessment will be undertaken at two-time points: baseline and after 16 weeks of exercise training.

Assessment will include VO2 peak, functional capacity, health-related quality of life, cognitive state and daily physical activity.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Having 50 - 90 years old.
  2. Not suffering chronic heart, respiratory or joint disease, taking medication or having a deteriorated level of mental health that could interfere in carrying out exercise programs.
  3. Having 0 or 1 responses positive in the Physical Activity Readiness Questionnaire (ParQ). Only item 6, related to mild vascular diseases.
  4. Being physically independent according to the scales Lawton and Brody, and Katz.

Exclusion Criteria:

  1. Having uncontrolled arterial hypertension.
  2. Having practiced during the previous 3 months or practicing at present a similar exercise to the one proposed in the study.
  3. Attending sessions less than 80%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-intensity interval training group
Frequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.
16 weeks of High-intensity interval training
Experimental: Moderate-intensity interval training group
Frequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.
16 weeks of Moderate-intensity interval training
No Intervention: Control group
Maintain their normal daily activities throughout the sixteen-week experimental period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyses changes in maximum oxygen consumption (VO2max).
Time Frame: Pre and post after sixteen weeks of intervention
A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2max).
Pre and post after sixteen weeks of intervention
Analyses changes in maximum oxygen consumption (VO2max).
Time Frame: Pre and post after sixteen weeks of intervention
VO2max was assessed using the 6-Minute Walk Test. The participant should walk the longest distance possible in 6 minutes by walking continuously the 42 metres indicated on the floor. It measures the distance in meters
Pre and post after sixteen weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyses changes in heart rate reached in ergometry.
Time Frame: Pre and post after sixteen weeks of intervention
Analyses during modified Balke treadmill protocol
Pre and post after sixteen weeks of intervention
Analyses changes in blood pressure reached in ergometry.
Time Frame: Pre and post after sixteen weeks of intervention
Analyses during modified Balke treadmill protocol
Pre and post after sixteen weeks of intervention
Analyses changes in maximum speed reached in ergometry.
Time Frame: Pre and post after sixteen weeks of intervention
Analyses during modified Balke treadmill protocol
Pre and post after sixteen weeks of intervention
Analyses changes in duration test reached in ergometry.
Time Frame: Pre and post after sixteen weeks of intervention
Analyses during modified Balke treadmill protocol
Pre and post after sixteen weeks of intervention
Analyses changes in fat percentage.
Time Frame: Pre and post after sixteen weeks of intervention.
Fat percentage (%) was assessed using bioimpedance analysis (OMROM BF-306).
Pre and post after sixteen weeks of intervention.
Analyses changes in body mass index (BMI).
Time Frame: Pre and post after sixteen weeks of intervention.
BMI was assessed using bioimpedance analysis (OMROM BF-306).
Pre and post after sixteen weeks of intervention.
Analyses changes in gait.
Time Frame: Pre and post after sixteen weeks of intervention.
Gait was assessed using the Timed Up and Go Test. To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.
Pre and post after sixteen weeks of intervention.
Analyses changes in balance.
Time Frame: Pre and post after sixteen weeks of intervention.
Balance was assessed using the One Leg Standing Test. This test consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 30 seconds.
Pre and post after sixteen weeks of intervention.
Analyses changes in lower body strength.
Time Frame: Pre and post after sixteen weeks of intervention.
Lower body strength was assessed using the Sit To Stand 30. For the Sit To Stand 30, the participant consist in measures how many repetition the participant can to stand up and sit down during 30 seconds.
Pre and post after sixteen weeks of intervention.
Analyses changes in upper body strength.
Time Frame: Pre and post after sixteen weeks of intervention.
Upper body strength was assessed using the Arm Curl Test (30). For this test, the participant consist in measures how many repetition the participant can to curl up and curl down during 30 seconds.
Pre and post after sixteen weeks of intervention.
Analyses changes in maximal handgrip strength.
Time Frame: Pre and post after sixteen weeks of intervention.
To measure the amount of strength developed by each hand in kg.
Pre and post after sixteen weeks of intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyses change in Self Assessed Physical Activity.
Time Frame: Pre and post after sixteen weeks of intervention.
Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
Pre and post after sixteen weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ismael Ballesta García, PhD. Student, Universidad de Almeria
  • Principal Investigator: María Carrasco Poyatos, PhD., Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 20, 2016

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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