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

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ClinicalTrials.gov Identifier: NCT03840330
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
María Carrasco Poyatos, Universidad de Almeria

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Aging Healthy Cardiovascular Risk Factor Physical Activity Other: Experimental: High-intensity interval training group Other: Experimental: Moderate-intensity interval training group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: HIT; MIT; GC
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women
Actual Study Start Date : December 20, 2015
Actual Primary Completion Date : February 1, 2016
Actual Study Completion Date : June 20, 2016

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.
Other: Experimental: High-intensity interval training group
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.
Other: Experimental: Moderate-intensity interval training group
16 weeks of Moderate-intensity interval training

No Intervention: Control group
Maintain their normal daily activities throughout the sixteen-week experimental period.



Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. Analyses changes in heart rate reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol

  2. Analyses changes in blood pressure reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol

  3. Analyses changes in maximum speed reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol

  4. Analyses changes in duration test reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840330


Sponsors and Collaborators
Universidad de Almeria
Investigators
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Principal Investigator: Ismael Ballesta García, PhD. Student Universidad de Almería
Principal Investigator: María Carrasco Poyatos, PhD. Universidad de Almería
  Study Documents (Full-Text)

Documents provided by María Carrasco Poyatos, Universidad de Almeria:
Informed Consent Form  [PDF] February 10, 2010


Additional Information:
Publications of Results:
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Responsible Party: María Carrasco Poyatos, Principal Investigator, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT03840330     History of Changes
Other Study ID Numbers: HIICT-OW/16
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Carrasco Poyatos, Universidad de Almeria:
High-intensity interval training
Circuit training
Elderly
Functional capacity
VO2 max
Cardiovascular parameters