Multicomponent Exercise Training in Frail Elderly

Not Applicable

Completed

• Conditions: Frailty; Exercise Addiction
• Interventions: Other: Exercise training

• Registration Number: NCT03986840
• Lead Sponsor: Universidad Europea de Madrid

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.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Study Start: 2019-09-01
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise program	Exercise training	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 HIIT exercise walking on a treadmill.
Daily activities	Exercise training	The patients who belongs to this group will continue to perform their daily routines.

Primary Outcome Measures

Name	Time	Method
Daily life activities	Change from baseline daily life activities at 6 weeks	Bartel index questionnaire
Thickness of the core and quadriceps muscles	Change from baseline muscle thickness at 6 weeks	Thickness assessment by ultrasound imaging
Heart rate variability	Change from baseline heart rate variability at 6 weeks	Heart rate variability by Suunto smart bell device
Muscle power	Change from baseline muscle power at 6 weeks	Force-velocity profile for the lower limb muscle power
Frailty	Change from baseline frailty at 6 weeks	Frailty with the Linda´s frailty criteria

Trial Locations

Locations (1)

Albertia Elderly Care Center; 🇪🇸 Madrid, Spain