NCT03986840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

June 7, 2019

Last Update Submit

January 9, 2020

Conditions

FrailtyExercise Addiction

Keywords

FrailtyExerciseAging

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Exercise program

EXPERIMENTAL

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

Daily activities

ACTIVE COMPARATOR

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

Other: Exercise training

Interventions

Exercise trainingOTHER

A multicomponent exercise program

Daily activitiesExercise program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women aged 75 years or more,
  • or more points in the Short Physical Performance Battery (SPPB)
  • Capability of walking (alone or assisted)

You may not qualify if:

  • Severity cognitive alterations
  • Severe disability on the Barthel score
  • Surgeries in the previous 6 months
  • Other any disorder that exclude for the exercise group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albertia Elderly Care Center

Madrid, Spain

Location

MeSH Terms

Conditions

FrailtyMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sergio López, MsC

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer, PhD

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 14, 2019

Study Start

September 1, 2019

Primary Completion

December 20, 2019

Study Completion

December 25, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

ES(1)