FrailtyNCT03986840
Multicomponent Exercise Training in Frail Elderly
A study testing Exercise training in people with Frailty and Exercise Addiction, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Exercise Addiction
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 25 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- Severity cognitive alterations
- Severe disability on the Barthel score
- Surgeries in the previous 6 months
- Other any disorder that exclude for the exercise group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty, Exercise Addiction
- Being tested
- Exercise training
- Keywords
- Frailty, Exercise, Aging
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
A multicomponent exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise training |
| Daily activities | Active comparator | The patients who belongs to this group will continue to perform their daily routines. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the core and quadriceps muscles
Thickness assessment by ultrasound imaging
Measured: Change from baseline muscle thickness at 6 weeks
Heart rate variability
Heart rate variability by Suunto smart bell device
Measured: Change from baseline heart rate variability at 6 weeks
Daily life activities
Bartel index questionnaire
Measured: Change from baseline daily life activities at 6 weeks
Muscle power
Force-velocity profile for the lower limb muscle power
Measured: Change from baseline muscle power at 6 weeks
Frailty
Frailty with the Linda´s frailty criteria
Measured: Change from baseline frailty at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Sep 2019
- Primary completion20 Dec 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero Morales, Universidad Europea de Madrid
- Investigators
- Sergio López, MsC, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986840
- Sponsor's protocol ID
- CIPI/
- Status last verified
- Jan 2020
- First submitted
- 7 Jun 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Multicomponent Exercise Training in Frail Elderly
- ClinicalTrials.gov ID
- NCT03986840
- Acronym / sponsor ID
- CIPI/
- Conditions
- Frailty, Exercise Addiction
- Keywords
- Frailty, Exercise, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Other: Exercise trainingThe 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. |
| Daily activities | Active comparator | Other: Exercise trainingThe patients who belongs to this group will continue to perform their daily routines. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Severity cognitive alterations
- Severe disability on the Barthel score
- Surgeries in the previous 6 months
- Other any disorder that exclude for the exercise group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingA multicomponent exercise program | Other | Daily activities, Exercise program |
Primary outcome
Thickness of the core and quadriceps muscles
Time frame: Change from baseline muscle thickness at 6 weeks
Thickness assessment by ultrasound imaging
Heart rate variability
Time frame: Change from baseline heart rate variability at 6 weeks
Heart rate variability by Suunto smart bell device
Daily life activities
Time frame: Change from baseline daily life activities at 6 weeks
Bartel index questionnaire
Muscle power
Time frame: Change from baseline muscle power at 6 weeks
Force-velocity profile for the lower limb muscle power
Frailty
Time frame: Change from baseline frailty at 6 weeks
Frailty with the Linda´s frailty criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio López, MsC principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Frailty and Exercise Addiction, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the core and quadriceps muscles (time frame: Change from baseline muscle thickness at 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.