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Clinical Trials/NCT06599034
NCT06599034
Completed
Not Applicable

Strategies to Increase Adherence to Physical Activity in a Phase III Cardiac Rehabilitation Program

Hospital de Manises1 site in 1 country70 target enrollmentOctober 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischaemic Heart Diseases
Sponsor
Hospital de Manises
Enrollment
70
Locations
1
Primary Endpoint
Patient Adherence to Physical Activity
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study consists of a randomised clinical trial of two parallel groups conducted in patients with ischaemic heart disease after completing phase II of Cardiac Rehabilitation (RHBC) at the Centro de Especialidades Mislata (CEM),Hospital Manises. The objective is to assess adherence to structured and unstructured physical activity in the long term (6 and 12 months). In addition to the usual recommendations in the Control Group (CG), a motivational programme will be added to the Intervention Group (IG), which will consist of establishing an individualised exercise plan reviewed monthly, in addition to maintaining continuous contact with the physiotherapist.

Detailed Description

Regular physical activity is an important measure in the prevention of cardiovascular diseases. In the phase II Cardiac Rehabilitation programme, the acquisition of healthy lifestyle habits is taught and encouraged, with physical exercise as a fundamental pillar of the programme. Physical exercise should be maintained throughout life (RHBC phase III) in order to continue to produce cardiovascular benefits. However, few studies focus on strategies to increase adherence to physical activity, despite its benefits in disease control. Motivation is one of the main barriers described by patients as well as the lack of contact with healthcare staff once the acute disease process is over. Therefore, we propose a simple, practical and economical intervention to increase adherence to physical activity, through a motivational programme, based on the establishment of objectives for each patient, carrying out an individualised physical exercise programme according to their preferences and needs, also establishing continuous contact with the physiotherapist to review and establish new objectives.

Registry
clinicaltrials.gov
Start Date
October 4, 2022
End Date
July 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital de Manises
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with ischaemic heart disease who have completed phase II of cardiac rehabilitation in CEM.
  • Patients of both sexes.
  • Patients classified as low, medium and high risk
  • Age between 18 and 70 years at the time of the cardiac event.

Exclusion Criteria

  • Older 70 years old

Outcomes

Primary Outcomes

Patient Adherence to Physical Activity

Time Frame: The groups, CG ad IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.

Registry of the characteristics of physical exercise following the principle: frequency, intensity, time and type of exercise

Participants Adherence to Physical Activity. Steps Control

Time Frame: The groups, control group (CG) and intervention group (IG), will be assessed at two times, 6 months and 12 months after the finish phase II of cardiac rehabilitation program (CRP).

Registry of daily physical activity, steps per day, by means of an OMROM HJ-321-E pedometer

Secondary Outcomes

  • Changes in Functional Capacity: measurement of ergometer(The groups, CG and IG, will be assessed at three times: at baseline, at finish phase II cardiac rehabilitation program, at 12 months after the finish phase II CRP.)
  • Changes in Blood Pressure(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP)
  • Changes in biochemical variables(The groups, CG and IG, will be assessed at three times: at baseline, at finish phase II cardiac rehabilitation program, at 12 months after the finish phase II CRP.)
  • Changes in abdominal circumference(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.)
  • Changes in the perception of quality of life(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP)
  • Changes in Muscle Mass Index( BMI)(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.)
  • Changes in anxiety levels(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.)
  • Changes in depresión levels(The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP)

Study Sites (1)

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