NCT04425057

Brief Summary

A study comparing 2 groups: interval training and control group. Interval training group will perform a physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Control group will not perform any physiotherapy program. Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

December 31, 2018

Last Update Submit

January 25, 2021

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (18)

  • Kinesiophobia

    Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).

    baseline

  • Kinesiophobia

    Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).

    2 months

  • Kinesiophobia

    Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).

    6 months

  • body mass index

    body mass index, m/kg2

    baseline

  • body mass index

    body mass index, m/kg2

    2 months

  • body mass index

    body mass index, m/kg2

    6 months

  • abdominal circumference

    abdominal circumference in cm

    baseline

  • abdominal circumference

    abdominal circumference in cm

    2 months

  • abdominal circumference

    abdominal circumference in cm

    6 months

  • body fat

    Bioimpedanciometer OMRON HBF-500INT body fat in %

    baseline

  • body fat

    Bioimpedanciometer OMRON HBF-500INT body fat in %

    2 months

  • body fat

    Bioimpedanciometer OMRON HBF-500INT body fat in %

    6 months

  • visceral fat

    Bioimpedanciometer OMRON HBF-500INT visceral fat in %

    baseline

  • visceral fat

    Bioimpedanciometer OMRON HBF-500INT visceral fat in %

    2 months

  • visceral fat

    Bioimpedanciometer OMRON HBF-500INT visceral fat in %

    6 months

  • muscle mass

    Bioimpedanciometer OMRON HBF-500INT muscle mass in %

    baseline

  • muscle mass

    Bioimpedanciometer OMRON HBF-500INT muscle mass in %

    2 months

  • muscle mass

    Bioimpedanciometer OMRON HBF-500INT muscle mass in %

    6 months

Secondary Outcomes (18)

  • anxiety

    baseline

  • anxiety

    2 months

  • anxiety

    6 months

  • depression

    baseline

  • depression

    2 months

  • +13 more secondary outcomes

Study Arms (2)

Interval training

EXPERIMENTAL

Physiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down. Aerobic exercises, resistance exercises, stretching

Other: Interval training

Control group

NO INTERVENTION

No physiotherapy

Interventions

Interval trainingOTHER
Interval training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosed of coronary artery disease
  • Discharged from hospital, less than 2 months

You may not qualify if:

  • Not able to move by themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PT

Study Record Dates

First Submitted

December 31, 2018

First Posted

June 11, 2020

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share