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

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

Tracking Information

• First Submitted Date: September 5, 2018
• First Posted Date: February 15, 2019
• Last Update Posted Date: March 6, 2019
• Actual Study Start Date: December 20, 2015
• Actual Primary Completion Date: February 1, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: High-intensity Training for Improving Physical Performance of Aged Women
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

HIT; MIT; GC

Masking: None (Open Label)
Primary Purpose: Basic Science

Condition

• Aging
• Healthy
• Cardiovascular Risk Factor
• Physical Activity

Intervention

• 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

• 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 *

• Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, 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. 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 García I, Rubio Arias JÁ, Ramos Campo DJ, Martínez González-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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 4, 2019): 54
• Original Actual Enrollment (submitted: February 11, 2019): 49
• Actual Study Completion Date: June 20, 2016
• Actual Primary Completion Date: February 1, 2016 (Final data collection date for primary outcome measure)

Eligibility 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%.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female

• Ages: 50 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03840330
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: María Carrasco Poyatos, Universidad de Almeria
• Study Sponsor: Universidad de Almeria
• Collaborators: Not Provided

Investigators

• 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