Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB) (PRE-FROB)

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).

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Elderly; Obese; Fragility
• Intervention / Treatment: Other: Intervention

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Consorci Sanitari Del Maresme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
  • Relevant physical limitations due to obesity
  • Sleep apnea-hypopnea syndrome (SAHS)
• Give written informed consent to participate in the study.

Exclusion Criteria:

• 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
• Amputation of a member
• Bariatric surgery tributary patient
• Institutionalized patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Intervention; Diet and physical exercises
No Intervention: Control; Clinical practise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	Frailty by L Fried criteria	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sarcopenia	Sarcopenia by European Working Group on Sarcopenia in Older People criteria	two years

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: frailty; elderly; prevention; physical exercise; obese
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 60/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No