Frailty is rapidly developing as a research field. The clinical studies listed below will evaluate clinical interventions aimed at preventing or delaying the onset of disability in older persons by targeting the frailty syndrome:
Healthy Life for Frail Malnourished Seniors Performed Together With Trained Lay Buddies
Principal Investigator: Thomas E. Dorner, Institute of Social Medicine, Centre for Public Health, Vienna, Austria
Background: In elderly subjects frailty and malnutrition are very common and can lead to serious health hazards, increase mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition can invert it.
Methods/Design: In this randomized, controlled trial 80 malnourished, frail, community-dwelling patients (≥ 65 years) hospitalized in wards for internal medicine are recruited. Additionally, 80 lay volunteers (≥ 50 years) named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in three standardized training sessions. These buddies visit the malnourished, frail subjects at home twice a week for about one hour during an initial period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct intervention to improve their fluid intake, their protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n=40) only gets home visits without any special intervention. After 10-12 weeks, both, the intervention and the control group, receive the nutrition intervention and the physical training. Health, nutrition and frailty status, physical fitness and body composition and chronic inflammation of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6 and 12 months.
Discussion: To the investigators knowledge this trial is the first of its kind to provide nutrition and physical activity intervention to malnourished, frail, community-dwelling subjects by trained lay buddies, in which the health status of buddies is also expected to improve. This study assesses the effectiveness of such an intervention. If successful, the intervention offers new perspectives for the management of frailty and malnutrition.
ClinicalTrials.gov Identifier: NCT01991639
Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)
Principal Investigator: Roger Fielding, Tufts University, Boston, MA, USA
Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.
ClinicalTrials.gov Identifier: NCT01542892
Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)
Principal Investigator: Rasmus Bechshøft, Bispebjerg Hospital, Copenhagen, Denmark
Principal Investigator: Lars Holm, Bispebjerg Hospital, Copenhagen, Denmark
Principal Investigator: Michael Kjaer, Bispebjerg Hospital, Copenhagen, Denmark
Principal Investigator: Søren Reitelseder, Bispebjerg Hospital, Copenhagen, Denmark
A minimum of 205 healthy elderly individuals (at least 65 years old) are recruited as subjects. Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (<16/16 or above). The five groups are: Heavy Resistance Training (N=35), Light Intensity Training (N=35), Protein Whey (N=50), Protein Collagen (N=50) and Carbohydrate (N=35). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content. Assessments will be performed at Baseline (before intervention start), and after 6 and 12 months of intervention and again at 18 months (after 6 months of follow up). The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention. The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will lose the quadriceps muscle cross sectional areas.
ClinicalTrials.gov Identifier: NCT02034760
Effectiveness of a Multifactorial Intervention on Frailty
Contact: Josep Maria Segura, Jordi Gol i Gurina Foundation, Barcelona, Spain
Contact: Laura Romera, Jordi Gol i Gurina Foundation, Barcelona, Spain
To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.
ClinicalTrials.gov Identifier: NCT01969526
Towards an In Hospital Care and Welfare Standard for Frail Elderly
Principal Investigator: Marcel G.M. Olde Rikkert, PhD, Radboud University, The Netherlands
The purpose of this study is to develop and examine the effectiveness of an intervention program for frail older patients admitted to hospital aimed at preventing functional decline and other hospital related negative outcomes.
ClinicalTrials.gov Identifier: NCT01273116
A Randomized Clinical Trial to Evaluate the Effectiveness of a Multi-Modal Intervention In Frail And Prefrail Older People with Type 2 Diabetes on Frailty and Quality of Life: The Mid-Frail Study
Principal Investigator: Leocadio Rodríguez Mañas, MD
The MID-Frail STUDY project focuses on the use of interventions designed to improve functional status and enhance quality of life (rather than traditional treatments such as glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes.
ClinicalTrials.gov Identifier: NCT01654341
Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study
Study Director: Lis Puggaard, PhD, University of Southern Denmark
The purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.
ClinicalTrials.gov Identifier: NCT00783055
The Impact of Exercise Training and Leucine Supplementation in Frail Elderly Women With an Exploration Into Mechanistic Explanations
Principal Investigator: Maria T. Forga, MD, Hospital Clínic de Barcelona, Nutrition and Dietetics Unit, Hospital Clínic de Barcelona, Spain
The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.
ClinicalTrials.gov Identifier: NCT01922167
Effect of Strength Training and Protein Supplementation on the Muscle Function in Very Old Nursinghome Residents
Study Chair: Michael Kjaer, MD, Prof., Head of department, Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital Recruiting Copenhagen NV, Denmark
Three months intervention study, investigating the effect of nutrient supplementation (including 20g of milk protein) twice daily with or without additional heavy resistance exercise three times weekly on muscle size, structure and function in 30 subjects at least 83 years of age. Primary hypothesis is that the group conducting exercise improves muscle size, structure and function.
ClinicalTrials.gov Identifier: NCT01997320
A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults
Principal Investigator: John A. Rathmacher, PhD, Metabolic Technologies, Iowa State University, South Dakota State University
The purpose of the study is to test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults. The second aim of the study is to determine if HMB and Vitamin D improves markers of bone turnover in adults aged 60 plus years.
ClinicalTrials.gov Identifier: NCT00874575
Multidomain Intervention to Prevent Disability in Elders (MINDED)
Principal Investigator: Matteo Cesari, MD, PhD, Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France
In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial.
ClinicalTrials.gov Identifier: NCT02082171
The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men
Contacts: Charles R. Gilkison, RN, MSN, and Kate M Randolph, BS, The University of Texas Medical Branch, Galveston Recruiting, Galveston, Texas, USA
The general hypothesis is that administration of testosterone to healthy, older men for 52 weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle strength, muscle mass, and bone density as standard of care (SOC), continuous administration of testosterone for 52 weeks.
ClinicalTrials.gov Identifier: NCT01417364
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults
Principal Investigator: Isabelle J. Dionne, PhD, Université de Sherbrooke, QC, Canada
This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:
– Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
– Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
– Examine the impact of exercise and proteins on liver enzymes;
– Examine the impact of exercise and proteins on a hormone that controls hunger;
– Evaluate the program’s impact on the ability of the body to produce energy.
ClinicalTrials.gov Identifier: NCT01883674
Ambulatory Geriatric Evaluation – Frailty Intervention Trial (AGE-FIT)
Principal Investigator: Anne W. Ekdahl, Linköping University, Sweden
The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.
ClinicalTrials.gov Identifier: NCT01446757
Nutrition and Exercise to Improve Protein Metabolism and Prevent Sarcopenia in Aging
Principal Investigator: Elena Volpi, MD, PhD, The University of Texas Medical Branch, Galveston, TX, USA
The investigators’ general hypothesis is that nutritional factors, including protein/energy malnutrition and/or an impaired response of muscle to nutrition, and inactivity play significant roles in developing sarcopenia, the involuntary loss of muscle mass and function with age. Therefore, age-specific prolonged interventions including nutritional manipulations and/or exercise may help to reduce, stabilize, or even reverse sarcopenia.
ClinicalTrials.gov Identifier: NCT00872911
The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults
Principal Investigator: Lewis Lipsitz, MD, Hebrew Rehabilitation Center, Roslindale, MA, USA
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.
ClinicalTrials.gov Identifier: NCT01126723
Ghrelin Plus Strength Training in Frail Elderly Study
Principal Investigator: Anne R. Cappola, MD, ScM, University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Philadelphia, PA, USA
Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
ClinicalTrials.gov Identifier: NCT01898611
The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons
Principal Investigator: Cornel C. Sieber, Prof. Dr., University of Erlangen-Nuremberg, Germany
Principal Investigator: Klaus Pfeifer, Prof. Dr., University of Erlangen-Nuremberg, Germany
This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.
ClinicalTrials.gov Identifier: NCT00783159
Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis
Responsible Party: Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria, Egypt
In the present study the aim was to determine the prevalence of sarcopenia and to evaluate the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle mass and strength in community-dwelling older adults with osteopenia/osteoporosis.
ClinicalTrials.gov Identifier: NCT01666522
Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia (HIPERPROT)
Principal Investigator: Vincenzo Malafarina, MD, Hospital San Juan de Dios, Pamplona, Spain
The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured.
The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level.
ClinicalTrials.gov Identifier: NCT01404195