Multicomponent Exercise Training in Frail Elderly

Effectiveness of the Multicomponent Exercise Training in Frail Elderly

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Exercise Addiction
• Intervention / Treatment: Other: Exercise training

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Albertia Elderly Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise program; 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.	Other: Exercise training; A multicomponent exercise program
Active Comparator: Daily activities; The patients who belongs to this group will continue to perform their daily routines.	Other: Exercise training; A multicomponent exercise program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Sergio López, MsC, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 25, 2019

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Aging; Frailty
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: CIPI/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No