Clinical Trials Logo

Clinical 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 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03000907
Study type Interventional
Source Consorci Sanitari del Maresme
Contact
Status Completed
Phase N/A
Start date January 23, 2017
Completion date December 20, 2019

See also
  Status Clinical Trial Phase
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Not yet recruiting NCT04874350 - A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia Phase 2
Not yet recruiting NCT04469504 - Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer N/A
Not yet recruiting NCT04370912 - Using Bedside Ultrasound to Screen for Sarcopenia in Older Adults
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Active, not recruiting NCT02912130 - Exercise and Nutrition Interventions in Age-related Sarcopenia N/A
Completed NCT02890290 - Effect Study of Marine Protein Hydrolysates to Prevent Loss of Muscle Mass and Physical Function in Frail Elderly N/A
Completed NCT02912338 - The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities N/A
Completed NCT02530723 - Functional Changes and Power Training in Older Women. N/A
Completed NCT03138265 - HIT Training in the Frail Elderly. N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A