Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03000907
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2016-12-20
Brief Title:
Efficacy of an Intervention to Prevent Frailty in Obese Elderly People PRE-FROB
Sponsor:
Consorci Sanitari del Maresme
Organization:
Consorci Sanitari del Maresme
Study Overview
Official Title:
Efficacy of a Multimodal Intervention in the Prevention of Frailty in Obese Elderly People and Study of the Pathophysiological Mechanisms Involved
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-FROB
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 CRPC reactive protein TNFTumor Necrosis Factor-alpha and leptin and g anabolic hormones IGF-1 ghrelin and testosterone
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 CRPC reactive protein TNFTumor Necrosis Factor-alpha and leptin and g anabolic hormones IGF-1 ghrelin and testosterone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None