Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicomponent Exercise Training in Frail Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986840
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Romero Morales, 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.


Condition or disease Intervention/treatment Phase
Frailty Exercise Addiction Other: Exercise training Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Multicomponent Exercise Training in Frail Elderly
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Thickness of the core and quadriceps muscles [ Time Frame: Change from baseline muscle thickness at 6 weeks ]
    Thickness assessment by ultrasound imaging

  2. Heart rate variability [ Time Frame: Change from baseline heart rate variability at 6 weeks ]
    Heart rate variability by Suunto smart bell device

  3. Daily life activities [ Time Frame: Change from baseline daily life activities at 6 weeks ]
    Bartel index questionnaire

  4. Muscle power [ Time Frame: Change from baseline muscle power at 6 weeks ]
    Force-velocity profile for the lower limb muscle power

  5. Frailty [ Time Frame: Change from baseline frailty at 6 weeks ]
    Frailty with the Linda´s frailty criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986840


Contacts
Layout table for location contacts
Contact: Carlos Romero Morales, PhD 696849723 carlosmorales92@hotmail.com

Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
Layout table for investigator information
Principal Investigator: Sergio López, MsC Universidad Europea de Madrid

Layout table for additonal information
Responsible Party: Carlos Romero Morales, Senior Lecturer, PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03986840     History of Changes
Other Study ID Numbers: CIPI/
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos Romero Morales, Universidad Europea de Madrid:
Frailty
Exercise
Aging

Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes