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Multicomponent Exercise Training in Frail Elderly

Primary Purpose

Frailty, Exercise Addiction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Frailty, Exercise, Aging

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Albertia Elderly Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise program

Daily activities

Arm Description

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.

The patients who belongs to this group will continue to perform their daily routines.

Outcomes

Primary Outcome Measures

Thickness of the core and quadriceps muscles
Thickness assessment by ultrasound imaging
Heart rate variability
Heart rate variability by Suunto smart bell device
Daily life activities
Bartel index questionnaire
Muscle power
Force-velocity profile for the lower limb muscle power
Frailty
Frailty with the Linda´s frailty criteria

Secondary Outcome Measures

Full Information

First Posted
June 7, 2019
Last Updated
January 9, 2020
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03986840
Brief Title
Multicomponent Exercise Training in Frail Elderly
Official Title
Effectiveness of the Multicomponent Exercise Training in Frail Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Exercise Addiction
Keywords
Frailty, Exercise, Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program
Arm Type
Experimental
Arm Description
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.
Arm Title
Daily activities
Arm Type
Active Comparator
Arm Description
The patients who belongs to this group will continue to perform their daily routines.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
A multicomponent exercise program
Primary Outcome Measure Information:
Title
Thickness of the core and quadriceps muscles
Description
Thickness assessment by ultrasound imaging
Time Frame
Change from baseline muscle thickness at 6 weeks
Title
Heart rate variability
Description
Heart rate variability by Suunto smart bell device
Time Frame
Change from baseline heart rate variability at 6 weeks
Title
Daily life activities
Description
Bartel index questionnaire
Time Frame
Change from baseline daily life activities at 6 weeks
Title
Muscle power
Description
Force-velocity profile for the lower limb muscle power
Time Frame
Change from baseline muscle power at 6 weeks
Title
Frailty
Description
Frailty with the Linda´s frailty criteria
Time Frame
Change from baseline frailty at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio López, MsC
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albertia Elderly Care Center
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Multicomponent Exercise Training in Frail Elderly

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