Multicomponent Exercise Training in Frail Elderly

Frailty Clinical Trial

Official title:

Effectiveness of the Multicomponent Exercise Training in Frail Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986840
• Other study ID #: CIPI/
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 25, 2019

Study information

• Verified date: January 2020
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 25, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Addiction
• Frailty

Intervention

Other:
• Exercise training
A multicomponent exercise program

Locations

Country	Name	City	State
Spain	Albertia Elderly Care Center	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

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