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Multicomponent Intervention for Physical Frailty and Sarcopenia (SPRINTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582138
Recruitment Status : Unknown
Verified February 2017 by Roberto Bernabei, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : October 21, 2015
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Roberto Bernabei, Catholic University of the Sacred Heart

Brief Summary:
The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme (physical activity, nutritional counselling/dietary intervention, and information and communications technology intervention) compared with a healthy aging lifestyle education programme on mobility disability, in non-disabled older people with physical frailty and sarcopenia.

Condition or disease Intervention/treatment Phase
Sarcopenia Other: Multicomponent intervention (MCI) Other: Healthy Aging Lifestyle Education (HALE) Not Applicable

Detailed Description:
As the life expectancy in European countries continues to increase, the maintenance of physical independence in older persons has become a major public health priority. The ability to ambulate without assistance is crucial for independent living and it is often the first ability to be lost in the process leading to disability. Older people who have impaired walking function need more assistance and are more likely to be placed in nursing homes, have a higher risk of morbidity, mortality and hospitalisation, and experience a reduced quality of life. The ultimate goals of the Sarcopenia and Physical fRailty IN older people: multicomponenT Treatment strategies (SPRINTT) project are to offer efficient treatment options, based on a multicomponent intervention including physical activity, nutrition and information and communications technology, to physically frail, sarcopenic older persons and to improve their quality of life. The result will directly contribute to the long-term sustainability and efficiency of health- and social-care systems. The conceptualisation of physical frailty and sarcopenia (PF&S) as proposed in SPRINTT will promote significant advancements over the traditional approaches by enabling the precise operationalisation of the condition, a clear identification of the affected population and the rapid translation of findings to the clinical arena.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multicomponent intervention (MCI)
The multicomponent intervention will include a physical activity programme, a nutritional intervention and an information and communications intervention.
Other: Multicomponent intervention (MCI)

The multicomponent intervention will include physical activity (PA), nutrition and information and communications technology (ICT). The PA will be of moderate intensity and will include aerobic, strength, flexibility, and balance training. Walking will be the primary mode of PA .

The nutritional intervention will combine individual nutritional assessment and personalised dietary recommendations to achieve:

  • a daily total energy intake of 25-30 kcal/kg body weight;
  • an average protein daily intake between 1.0 and 1.2 g/Kg/body weight.

The ICT component will involve the use of an ad hoc technological device to record actimetry data to support the elaboration of a personalised training programme.


Active Comparator: Healthy Aging Lifestyle Education (HALE)
The health aging lifestyle education programme will be based on workshops. Participants will receive information on a variety of topics of relevance to older persons (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop.
Other: Healthy Aging Lifestyle Education (HALE)
The healthy aging lifestyle education programme will be based on a workshop series. Participants will receive information on a variety of topics of relevance to older adults (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop.




Primary Outcome Measures :
  1. Incident of major mobility disability [ Time Frame: 36 months ]
    Incident inability to complete the 400-metre walk test (incidence of major mobility disability)


Secondary Outcome Measures :
  1. Changes in lower extremity physical performance [ Time Frame: 36 months ]
    Changes in short physical performance battery (SPPB) summary score

  2. Changes in upper extremity muscle strength [ Time Frame: 36 months ]
    Changes in handgrip strength test performance (kg)

  3. Changes in functional status (activities of daily living) [ Time Frame: 36 months ]
    Changes in Activities of Daily Living (ADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)

  4. Changes in functional status (instrumental activities of daily living) [ Time Frame: 36 months ]
    Changes in Instrumental Activities of Daily Living (IADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)

  5. Changes in crude appendicular lean mass [ Time Frame: 36 months ]
    Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry

  6. Changes in body mass index-adjusted appendicular lean mass [ Time Frame: 36 months ]
    Changes in body mass index-adjusted appendicular lean mass (adimensional) by Dual Energy X-Ray Absorptiometry

  7. Persistent mobility disability [ Time Frame: 36 months ]
    Inability to complete the 400-metre walk test at two consecutive semiannual visits

  8. Changes in body weight [ Time Frame: 36 months ]
    Changes in body weight (kg)

  9. Changes in body mass index [ Time Frame: 36 months ]
    Changes in body mass index (kg/m^2)

  10. Changes in mid-arm circumference [ Time Frame: 36 months ]
    Changes in mid-arm circumference (cm)

  11. Changes in waist circumference [ Time Frame: 36 months ]
    Changes in waist circumference (cm)

  12. Changes in hip circumference [ Time Frame: 36 months ]
    Changes in hip circumference (cm)

  13. Changes in calf circumference [ Time Frame: 36 months ]
    Changes in calf circumference (cm)

  14. Changes in nutritional status [ Time Frame: 36 months ]
    Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score

  15. Changes in cognitive function [ Time Frame: 36 months ]
    Changes in Mini Mental State Examination (MMSE) score

  16. Changes in mood [ Time Frame: 36 months ]
    Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score

  17. Incidence of self-reported falls [ Time Frame: 36 months ]
    Number of falls assessed by questionnaires

  18. Incidence of injurious falls [ Time Frame: 36 months ]
    Number of injurious falls assessed by questionnaires

  19. Changes in quality of life [ Time Frame: 36 months ]
    Changes in EuroQoL-5D (EQ5D) score

  20. Changes in the use of healthcare services [ Time Frame: 36 months ]
    Health economics questionnaire

  21. All-cause mortality [ Time Frame: 36 months ]
    Mortality rate

  22. Cost effectiveness [ Time Frame: 36 months ]
    Cost effectiveness analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Short Physical Performance Battery (SPPB) score between 3 (included) and 9 (included);
  2. Able to complete the 400-m walk test within 15 min without sitting down, help from another person, use of a walker, or stopping for more than 1 minute at a time;
  3. Presence of low muscle mass based on Dual Energy X-Ray Absorptiometry (DXA) scan, according to the Foundation for the National Institutes of Health Sarcopenia Project (FNIH) criteria:

    • Body mass index-adjusted appendicular lean mass (aLM; i.e., the sum of lean mass from both arms and legs): <0.789 in men, and <0.512 in women OR
    • aLM <19.75 kg in men and <15.02 kg in women
  4. Willingness to be randomised to either intervention group and to follow the study protocol.

Exclusion criteria:

General

  1. Unable or unwilling to provide informed consent or accept randomisation to either study group.
  2. Plans to relocate out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year;
  3. Residence in long-term care;
  4. Household member enrolled in the study.

Clinical conditions:

  1. Current diagnosis of schizophrenia, other psychotic or bipolar disorder;
  2. Consumption of more than 14 alcoholic drinks per week;
  3. Difficulty communicating with the study personnel due to speech, language, or (non-corrected) hearing problems;
  4. Mini Mental State Examination lower than 24/30;
  5. Severe osteoarthritis (e.g., awaiting joint replacement) that would interfere with the ability to participate fully in either study arm;
  6. Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer);
  7. Lung disease requiring regular use of supplemental oxygen;
  8. Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents;
  9. Severe cardiovascular disease (including New York Heart Association class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
  10. Upper and/or lower extremity amputation;
  11. Peripheral arterial disease Lériche-Fontaine 3 or 4;
  12. Parkinson's disease or other progressive neurological disorder;
  13. Renal disease requiring dialysis;
  14. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline 400-metre walk test;
  15. Current participation in a structured exercise programme, physical therapy or cardiopulmonary rehabilitation;
  16. Current enrolment in another randomised clinical trial involving lifestyle, nutrition, or pharmaceutical interventions;
  17. Other medical, psychiatric, or behavioural factors that in the judgment of the principal investigator may interfere with the study participation or the ability to autonomously follow either the multicomponent or the healthy aging lifestyle education programmes;
  18. Other illness of such severity that life expectancy is expected to be less than 12 months;
  19. Clinical judgment concerning safety or non-compliance.

Temporary exclusion criteria

  1. Uncontrolled hypertension (systolic blood pressure >200 mm Hg, or diastolic blood pressure >110 mm Hg);
  2. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent hypoglycaemia;
  3. Hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  4. Serious cardiac conduction disorder (e.g., third-degree heart block), uncontrolled arrhythmia, new Q waves within the past 6 months or ST-segment depression (>3 mm) on the electrocardiogram;
  5. Myocardial infarction, major heart surgery (i.e., valve replacement or coronary bypass graft), stroke, deep vein thrombosis, or pulmonary embolism in the past 6 months;
  6. Use of growth hormone, oestrogens, progesterone, or testosterone supplementation in the past 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582138


Contacts
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Contact: Emanuele Marzetti, MD, PhD +39 06 3015 ext 5559 emarzetti@live.com
Contact: Riccardo Calvani, PhD +39 06 3015 ext 5559 riccardo.calvani@gmail.com

Locations
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Italy
Catholic University of the Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Emanuele Marzetti, MD, PhD    +39 0630155559    emarzetti@live.com   
Contact: Riccardo Calvani, PhD    +39 0630155559    riccardo.calvani@gmail.com   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Francesco Landi, MD, PhD Catholic University of the Sacred Heart
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Bernabei, Professor of Geriatrics, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02582138    
Other Study ID Numbers: 115621
IMI-JU-09-2013-02 ( Other Grant/Funding Number: Innovative Medicine Initiative )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Roberto Bernabei, Catholic University of the Sacred Heart:
physical frailty
sarcopenia
exercise
nutrition
information and communications technology
Additional relevant MeSH terms:
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Sarcopenia
Frailty
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical