NCT03840330

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

September 5, 2018

Last Update Submit

March 4, 2019

Conditions

Keywords

High-intensity interval trainingCircuit trainingElderlyFunctional capacityVO2 maxCardiovascular parameters

Outcome Measures

Primary Outcomes (2)

  • Analyses changes in maximum oxygen consumption (VO2max).

    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).

    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 Outcomes (11)

  • Analyses changes in heart rate reached in ergometry.

    Pre and post after sixteen weeks of intervention

  • Analyses changes in blood pressure reached in ergometry.

    Pre and post after sixteen weeks of intervention

  • Analyses changes in maximum speed reached in ergometry.

    Pre and post after sixteen weeks of intervention

  • Analyses changes in duration test reached in ergometry.

    Pre and post after sixteen weeks of intervention

  • Analyses changes in fat percentage.

    Pre and post after sixteen weeks of intervention.

  • +6 more secondary outcomes

Other Outcomes (1)

  • Analyses change in Self Assessed Physical Activity.

    Pre and post after sixteen weeks of intervention.

Study Arms (3)

High-intensity interval training group

EXPERIMENTAL

Frequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.

Other: Experimental: High-intensity interval training group

Moderate-intensity interval training group

EXPERIMENTAL

Frequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.

Other: Experimental: Moderate-intensity interval training group

Control group

NO INTERVENTION

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

Interventions

16 weeks of High-intensity interval training

High-intensity interval training group

16 weeks of Moderate-intensity interval training

Moderate-intensity interval training group

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ismael Ballesta García, PhD. Student

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR
  • María Carrasco Poyatos, PhD.

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: HIT; MIT; GC
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2018

First Posted

February 15, 2019

Study Start

December 20, 2015

Primary Completion

February 1, 2016

Study Completion

June 20, 2016

Last Updated

March 6, 2019

Record last verified: 2019-03