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Clinical Trials/NCT03986840
NCT03986840
Completed
Not Applicable

Effectiveness of the Multicomponent Exercise Training in Frail Elderly

Universidad Europea de Madrid1 site in 1 country34 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Universidad Europea de Madrid
Enrollment
34
Locations
1
Primary Endpoint
Daily life activities
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of the present study will be to assess the effectiveness of the multicomponent exercise training in frail for the physical function, frailty and performance.

All the individuals will be assessed two times.

Detailed Description

This will be a experimental, randomized controlled intervention study in frail. Subjects will be recruited at the Albertia Care Center, Madrid. The exercise training group will developed a concurrent training 3 days per week during 6 weeks. The control group will follow an usual care also for 6 weeks. The main variables will be as follows: * Ultrasound imaging measurements for the lower limb: core muscles, vastus medialis, rectus femoris, vastus intermedius, gastrocnemius, soleus. We will employed a General Electric (GE) Ultrasound device in B mode to assess the thickness of the muscles. * Heart rate variability with a Suunto smart bell. * Activities of daily living with the Bartel index. * Force-velocity profile and muscle power. * Frailty with the Linda´s frailty criteria. The exercise program was applied for 6 weeks. A total of 18 sessions were distributed in 3 weekly sessions. The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular high intensity interval training (HIIT) exercise walking on a treadmill. One measurements will be taken (pre), the second (post) measurements will be performed at 6 weeks.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
December 25, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Europea de Madrid
Responsible Party
Principal Investigator
Principal Investigator

Carlos Romero Morales

Senior Lecturer, PhD

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 75 years or more,
  • 2 or more points in the Short Physical Performance Battery (SPPB)
  • Capability of walking (alone or assisted)

Exclusion Criteria

  • Severity cognitive alterations
  • Severe disability on the Barthel score
  • Surgeries in the previous 6 months
  • Other any disorder that exclude for the exercise group.

Outcomes

Primary Outcomes

Daily life activities

Time Frame: Change from baseline daily life activities at 6 weeks

Bartel index questionnaire

Thickness of the core and quadriceps muscles

Time Frame: Change from baseline muscle thickness at 6 weeks

Thickness assessment by ultrasound imaging

Heart rate variability

Time Frame: Change from baseline heart rate variability at 6 weeks

Heart rate variability by Suunto smart bell device

Muscle power

Time Frame: Change from baseline muscle power at 6 weeks

Force-velocity profile for the lower limb muscle power

Frailty

Time Frame: Change from baseline frailty at 6 weeks

Frailty with the Linda´s frailty criteria

Study Sites (1)

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