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

NCT ID: NCT03000907

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-23
• Study Completion Date: 2019-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: OTHER

Diet and physical exercises

Control

Clinical practise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention

Diet and physical exercises

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari del Maresme

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Countries

Spain

Other Identifiers

60/16

Identifier Type: -

Identifier Source: org_study_id