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

NCT03000907 | Completed

• 1 other identifier: 60/16
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

prevention; frailty; obese; elderly; physical exercise

Outcome Measures

Primary Outcomes (1)

• Frailty

  Frailty by L Fried criteria

  two years

Secondary Outcomes (1)

• Sarcopenia

  two years

Study Arms (2)

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.

Other: Intervention

Control

NO INTERVENTION

Clinical practise

Interventions

Intervention OTHER

Diet and physical exercises

Intervention

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Obesity; Frailty; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: January 23, 2017
• Primary Completion: April 26, 2019
• Study Completion: December 20, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)