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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

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE December 20, 2015
Actual Primary Completion Date February 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • 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).
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
  • 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).
  • 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 46 metres indicated on the floor. It measures the distance in meters
Change History Complete list of historical versions of study NCT03840330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Analyses changes in heart rate reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in blood pressure reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in maximum speed reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in duration test reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
  • Analyses changes in heart rate reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in blood pressure reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in maximum speed reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • Analyses changes in duration test reached in ergometry. [ Time Frame: Pre and post after sixteen weeks of intervention ]
    Analyses during modified Balke treadmill protocol
  • 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).
  • Analyses changes in body max index (BMI). [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    BMI was assessed using bioimpedance analysis (OMROM BF-306).
  • Analyses changes in dynamic balance. [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    Dynamic balance was assessed using the Timed Up and Go Test. To stand up from a standard arms chair, walk 2.44 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.
  • Analyses changes in static monopodal balance. [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    Monopodal static 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 45 seconds.
  • Analyses changes in lower body strength at 16 weeks. [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    Lower body strength was assessed using the Sit To Stand 60. For the Sit To Stand 60, the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds.
  • Analyses changes in upper body strength. [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    Upper body strength was assessed using the Curl Arm Test (60). For this test, the participant consist in measures how many repetition the participant can to curl up and curl down during 60 seconds.
  • Analyses changes in manual grip strength. [ Time Frame: Pre and post after sixteen weeks of intervention. ]
    To measure the amount of strength developed by each hand in kg.
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High-intensity Training for Improving Physical Performance of Aged Women
Official Title  ICMJE Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
HIT; MIT; GC
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Healthy
  • Cardiovascular Risk Factor
  • Physical Activity
Intervention  ICMJE
  • Other: Experimental: High-intensity interval training group
    16 weeks of High-intensity interval training
  • Other: Experimental: Moderate-intensity interval training group
    16 weeks of Moderate-intensity interval training
Study Arms  ICMJE
  • Experimental: High-intensity interval training group
    Frequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.
    Intervention: Other: Experimental: High-intensity interval training group
  • Experimental: Moderate-intensity interval training group
    Frequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.
    Intervention: Other: Experimental: Moderate-intensity interval training group
  • No Intervention: Control group
    Maintain their normal daily activities throughout the sixteen-week experimental period.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
54
Original Actual Enrollment  ICMJE
 (submitted: February 11, 2019)
49
Actual Study Completion Date  ICMJE June 20, 2016
Actual Primary Completion Date February 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03840330
Other Study ID Numbers  ICMJE HIICT-OW/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party María Carrasco Poyatos, Universidad de Almeria
Study Sponsor  ICMJE Universidad de Almeria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ismael Ballesta García, PhD. Student Universidad de Almería
Principal Investigator: María Carrasco Poyatos, PhD. Universidad de Almería
PRS Account Universidad de Almeria
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP