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AgingAHIITATENCT03840330

High-intensity Training for Improving Physical Performance of Aged Women

A study testing Experimental: High-intensity interval training group and Experimental: Moderate-intensity interval training group in people with Aging and Healthy, run by Universidad de Almeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aging, Healthy, Cardiovascular Risk Factor
What is being tested?
Experimental: High-intensity interval training group and Experimental: Moderate-intensity interval training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
20 Dec 2015to 20 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%.

About this study

Official title: Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women

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.

Being tested
Experimental: High-intensity interval training group, Experimental: Moderate-intensity interval training group
Keywords
High-intensity interval training, Circuit training, Elderly, Functional capacity, VO2 max, Cardiovascular parameters
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: High-intensity interval training groupOther

    16 weeks of High-intensity interval training

  • Experimental: Moderate-intensity interval training groupOther

    16 weeks of Moderate-intensity interval training

Study groups in NCT03840330
Study groupRoleWhat they receive
High-intensity interval training groupExperimentalFrequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.
Receives: Other: Experimental: High-intensity interval training group
Moderate-intensity interval training groupExperimentalFrequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.
Receives: Other: Experimental: Moderate-intensity interval training group
Control groupNo interventionMaintain their normal daily activities throughout the sixteen-week experimental period.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: Pre and post after sixteen weeks of intervention

Secondary outcomes (11)

  1. Analyses changes in heart rate reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Measured: Pre and post after sixteen weeks of intervention

  2. Analyses changes in blood pressure reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Measured: Pre and post after sixteen weeks of intervention

  3. Analyses changes in maximum speed reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Measured: Pre and post after sixteen weeks of intervention

  4. Analyses changes in duration test reached in ergometry.

    Analyses during modified Balke treadmill protocol

    Measured: Pre and post after sixteen weeks of intervention

  5. Analyses changes in fat percentage.

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

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Pre and post after sixteen weeks of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start20 Dec 2015
  3. Primary completion1 Feb 2016
  4. Study completion20 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
HIT; MIT; GC
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840330
Sponsor's protocol ID
HIICT-OW/16
Acronym
AHIITATE
Status last verified
Mar 2019
First submitted
5 Sep 2018
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: High-intensity interval training group and Experimental: Moderate-intensity interval training group in people with Aging and Healthy, run by Universidad de Almeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analyses changes in maximum oxygen consumption (VO2max). (time frame: Pre and post after sixteen weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840330, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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