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CompletedNCT03840330AHIITATEUpdated Mar 6, 2019

High-intensity Training for Improving Physical Performance of Aged Women

An interventional study of Experimental: High-intensity interval training group and Experimental: Moderate-intensity interval training group in Aging, Healthy and Cardiovascular Risk Factor, sponsored by Universidad de Almeria. Completed. Open to female participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2015, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Aging
  • Healthy
  • Cardiovascular Risk Factor
  • Physical Activity

Keywords

  • High-intensity interval training
  • Circuit training
  • Elderly
  • Functional capacity
  • VO2 max
  • Cardiovascular parameters
03

In context

Lead sponsor

Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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%.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    Control group

    Maintain their normal daily activities throughout the sixteen-week experimental period.

Interventions

  • OtherExperimental: High-intensity interval training group

    16 weeks of High-intensity interval training

  • OtherExperimental: Moderate-intensity interval training group

    16 weeks of Moderate-intensity interval training

06

What researchers measure

Primary outcomes

  1. Analyses changes in maximum oxygen consumption (VO2max).

    A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2max).

    Time frame: Pre and post after sixteen weeks of intervention

  2. Analyses changes in maximum oxygen consumption (VO2max).

    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

    Time frame: Pre and post after sixteen weeks of intervention

Secondary outcomes

  1. Analyses changes in heart rate reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Time frame: Pre and post after sixteen weeks of intervention

  2. Analyses changes in blood pressure reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Time frame: Pre and post after sixteen weeks of intervention

  3. Analyses changes in maximum speed reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Time frame: Pre and post after sixteen weeks of intervention

  4. Analyses changes in duration test reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Time frame: Pre and post after sixteen weeks of intervention

  5. Analyses changes in fat percentage.

    Fat percentage (%) was assessed using bioimpedance analysis (OMROM BF-306).

    Time frame: Pre and post after sixteen weeks of intervention.

  6. Analyses changes in body mass index (BMI).

    BMI was assessed using bioimpedance analysis (OMROM BF-306).

    Time frame: Pre and post after sixteen weeks of intervention.

  7. Analyses changes in gait.

    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.

    Time frame: Pre and post after sixteen weeks of intervention.

  8. Analyses changes in balance.

    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.

    Time frame: Pre and post after sixteen weeks of intervention.

  9. Analyses changes in lower body strength.

    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.

    Time frame: Pre and post after sixteen weeks of intervention.

  10. Analyses changes in upper body strength.

    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.

    Time frame: Pre and post after sixteen weeks of intervention.

  11. Analyses changes in maximal handgrip strength.

    To measure the amount of strength developed by each hand in kg.

    Time frame: Pre and post after sixteen weeks of intervention.

Other outcomes

  1. Analyses change in Self Assessed Physical Activity.

    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.

    Time frame: Pre and post after sixteen weeks of intervention.

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 17548726 ↗
  • 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. PubMed 19915859 ↗
  • 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. PubMed 24880226 ↗
  • 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. PubMed 29650445 ↗

Study documents

  • Informed consent form · Feb 10, 2010

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03840330
Lead sponsor
Universidad de Almeria
Responsible party
María Carrasco Poyatos (Principal Investigator, Universidad de Almeria) — Principal investigator
First posted
Feb 15, 2019
Start date
Dec 20, 2015
Primary completion
Feb 1, 2016
Completion
Jun 20, 2016
Last update
Mar 6, 2019

Study contacts

Ismael Ballesta García, PhD. Student
principal investigator · Universidad de Almeria
María Carrasco Poyatos, PhD.
principal investigator · Universidad de Almeria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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