FragilityPRE-FROBNCT03000907
Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB)
A study testing Intervention in people with Fragility and Sarcopenia, run by Consorci Sanitari del Maresme at 1 site in Spain.
Trial summary
Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical… Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Fragility, Sarcopenia, Obese
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2017to 20 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- BMI between 30 and 39 kg / m2
- Non Frail according to L. Fried criteria
- At least one of the following diagnoses:
- Oral glucose intolerance or type 2 diabetes without insulin therapy.
- Dyslipidemia (cholesterolemia> 200 mg / dl or triglyceridemia> 150 mg / dl)
- Arterial hypertension (AT> 120/90 mm Hg)
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- Relevant physical limitations due to obesity
- Sleep apnea-hypopnea syndrome (SAHS)
- Give written informed consent to participate in the study.
Who cannot join
- Dementia or other neurodegenerative diseases (Parkinson's disease)
- Neuromuscular diseases
- Severe psychiatric illness that, at the discretion of the physician, prevents good compliance with the study intervention
- Active cancer
- Life expectancy less than 6 months
- Hemiplegia secondary to stroke
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- Amputation of a member
- Bariatric surgery tributary patient
- Institutionalized patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Multimodal Intervention in the Prevention of Frailty in Obese Elderly People and Study of the Pathophysiological Mechanisms Involved
Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical activity. All this favors the loss of mass and muscular function (sarcopenia), a key component of the fragility and the functional deterioration.
Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the prevention of frailty in obese elderly people, as well as to know the main mechanisms involved in the frailty process.
Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of age, obese (BMI ≥30), without criteria of fragility and living in the community. Study intervention: multimodal and personalized intervention with the support of a "personal trainer" that has two main axes of action: a) diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls and b) physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Main outcome measures (to be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).
- Conditions
- Fragility, Sarcopenia, Obese, Elderly
- Being tested
- Intervention
- Keywords
- prevention, frailty, obese, elderly, physical exercise
- Medical subject headings
- Sarcopenia, Obesity, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Diet and physical exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls.
* physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Receives: Other: Intervention |
| Control | No intervention | Clinical practise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty by L Fried criteria
Measured: two years
Secondary outcomes (1)
Sarcopenia
Sarcopenia by European Working Group on Sarcopenia in Older People criteria
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start23 Jan 2017
- Primary completion26 Apr 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000907
- Sponsor's protocol ID
- 60/16
- Acronym
- PRE-FROB
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2016
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multimodal Intervention in the Prevention of Frailty in Obese Elderly People and Study of the Pathophysiological Mechanisms Involved
- ClinicalTrials.gov ID
- NCT03000907
- Acronym / sponsor ID
- PRE-FROB / 60/16
- Conditions
- Fragility, Sarcopenia, Obese, Elderly
- Keywords
- prevention, frailty, obese, elderly, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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.
Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical activity. All this favors the loss of mass and muscular function (sarcopenia), a key component of the fragility and the functional deterioration.
Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the prevention of frailty in obese elderly people, as well as to know the main mechanisms involved in the frailty process.
Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of age, obese (BMI ≥30), without criteria of fragility and living in the community. Study intervention: multimodal and personalized intervention with the support of a "personal trainer" that has two main axes of action: a) diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls and b) physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Main outcome measures (to be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intervention* diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls. * physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. |
| Control | No intervention | –Clinical practise |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- BMI between 30 and 39 kg / m2
- Non Frail according to L. Fried criteria
- At least one of the following diagnoses:
- Give written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Dementia or other neurodegenerative diseases (Parkinson's disease)
- Neuromuscular diseases
- Severe psychiatric illness that, at the discretion of the physician, prevents good compliance with the study intervention
- Active cancer
- Life expectancy less than 6 months
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 |
|---|---|---|
| InterventionDiet and physical exercises | Other | Intervention |
Primary outcome
Frailty
Time frame: two years
Frailty by L Fried criteria
1 secondary outcome
Sarcopenia
Time frame: two years
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 22 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Fragility and Sarcopenia, run by Consorci Sanitari del Maresme 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 9 inclusion and 9 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 22 Jul 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?
Frailty (time frame: two years). 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 22 Jul 2020.