- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840330
High-intensity Training for Improving Physical Performance of Aged Women (AHIITATE)
Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having 50 - 90 years old.
- 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.
- Having 0 or 1 responses positive in the Physical Activity Readiness Questionnaire (ParQ). Only item 6, related to mild vascular diseases.
- Being physically independent according to the scales Lawton and Brody, and Katz.
Exclusion Criteria:
- Having uncontrolled arterial hypertension.
- Having practiced during the previous 3 months or practicing at present a similar exercise to the one proposed in the study.
- Attending sessions less than 80%.
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Ismael Ballesta García, PhD. Student, Universidad de Almeria
- Principal Investigator: María Carrasco Poyatos, PhD., Universidad de Almeria
Publications and helpful links
General Publications
- Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
- Guiraud T, Juneau M, Nigam A, Gayda M, Meyer P, Mekary S, Paillard F, Bosquet L. Optimization of high intensity interval exercise in coronary heart disease. Eur J Appl Physiol. 2010 Mar;108(4):733-40. doi: 10.1007/s00421-009-1287-z.
- Huang SC, Wong MK, Lin PJ, Tsai FC, Fu TC, Wen MS, Kuo CT, Wang JS. Modified high-intensity interval training increases peak cardiac power output in patients with heart failure. Eur J Appl Physiol. 2014 Sep;114(9):1853-62. doi: 10.1007/s00421-014-2913-y. Epub 2014 Jun 1.
- Ballesta Garcia I, Rubio Arias JA, Ramos Campo DJ, Martinez Gonzalez-Moro I, Carrasco Poyatos M. High-intensity Interval Training Dosage for Heart Failure and Coronary Artery Disease Cardiac Rehabilitation. A Systematic Review and Meta-analysis. Rev Esp Cardiol (Engl Ed). 2019 Mar;72(3):233-243. doi: 10.1016/j.rec.2018.02.015. Epub 2018 Apr 9. English, Spanish.
Helpful Links
- Carrasco, M., Navarro, M.D., Martínez, I., Reche-Orenes, D. (2016). Daily physical activity impact in old women bone density and grip strength. Nutrición Hospitalaria, 33(6), 1305-1311.
- Carrasco, M., Martínez, I., Navarro, M.D. (2015). Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte, 21(1), 22-26.
- Carrasco, M., Vaquero, M. (2012). Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science, 12(2), 193-200.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HIICT-OW/16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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