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Completed

NCT Number: NCT03986840

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.

Completed

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Key information

Conditions

Frailty Behavior Exercise Addiction Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albertia Elderly Care Center

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

A multicomponent exercise program

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Effectiveness of the Multicomponent Exercise Training in Frail Elderly

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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