The primaire objective is to evaluate the effectiveness of a multicomponent intervention (MCI) programme (physical activity [PA], nutritional counselling/dietary intervention, and information & communication technology [ICT] intervention)…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primaire efficacy endpoint is the Incidence of mobility disability defined
as incident inability of the participant to complete a 400-m walk within 15 min
without sitting, help of another person, use of a walker, or stopping for more
than 1 minute at a time.
Secondary outcome
The secondary efficacy endpoint are: changes in physical performance measures,
body composition, anthropometric parameters, nutritional status, quality of
life, cognitive function and mood, incidence of falls, differences in use of
healthcare services and mortality rate.
Background summary
The demographic transition Europe has experienced over the last several decades
poses an unprecedented challenge for both a societal and healthcare
perspective. The existing healthcare systems built around the traditional
medical paradigm of patients suffering from a single acute illness are largely
unprepared to face the increasing demands for health services that can
specifically address the medical needs of older, multi-morbid people 18. It
follows that, on the one hand, a large and growing segment of the older
European population is currently suffering from medical conditions that cannot
be efficiently managed by the existing healthcare services. On the other hand,
although prolongation of life remains an important public health goal, of even
greater significance is that extended life includes preservation of the
capacity to live independently and function well. Indeed, disabling conditions
have shown to be extremely burdening for the individual as well as for the
sustainability of healthcare systems 19. In this scenario, the geriatric
syndrome of frailty gains special interest and importance.
The recognition of sarcopenia as a major component of PF implies that
interventions specifically targeting the skeletal muscle may provide
therapeutic and preventive advantages against frailty and its clinical
correlates. However, although observational studies and some RCTs have
suggested a positive effect of regular physical activity (PA) and nutritional
interventions on improving physical function and/or reducing symptoms of
disability in healthy older individuals and those at risk for mobility
disability, definite evidence from high-quality, large-scale clinical trials is
still lacking. In this regard, it is important to recognise that short-term
gains in intermediate outcomes of PA programmes, such as strength and aerobic
capacity, are insufficient to prove that such programmes can truly prevent
frailty and disability.
The SPRINTT long-term clinical trial is part of a larger a project being
conducted under the auspices of IMI, and will focus on PF&S in older persons.
The SPRINTT project is geared to produce significant advancements in the
management of frail elders by promoting a consensus among academia, regulators,
industry, and patients* representatives. The SPRINTT project will produce novel
and meaningful data on a large sample of *real-practice* older adults to define
reference values specific for the European population to be potentially used in
the future for regulatory and research purposes.
Study objective
The primaire objective is to evaluate the effectiveness of a multicomponent
intervention (MCI) programme (physical activity [PA], nutritional
counselling/dietary intervention, and information & communication technology
[ICT] intervention) compared with a healthy aging lifestyle education (HALE)
programme on the hazard rate of mobility disability, in non-disabled older
people with physical frailty and sarcopenia (PF&S). The secondary objectives
are: to compare and evaluate the MCI and the HALE programme on relevant
health-related outcomes, predicting outcomes, safety and tolerability; to
refine the definition of PF&S and evaluate and qualify the role of the
different variables and biomarkers in predicting outcomes and to develop a
health economic model for the clinical take-in-charge of PF&S.
Study design
International, multicentre, single-blind, 2 parallel groups, randomised trial.
Intervention
: Duration of the intervention will be 24 months; an extension up to 36 months
may be proposed based on study power consideration. Participants will be
randomly divided into two intervention groups: the Multi-Component Intervention
(MCI) groups or the Healthy Aging Lifestyle Education (HALE) group. During the
study, participants in both groups could be prescribed vitamin D
supplementation in case of insufficiency or deficiency, in accordance with
their primary care physician. The MCI programme will consist of following
elements: a PA program (including aerobic, strength, flexibility and balance
training);a full nutritional assessment and dietary counselling; an ICT
intervention. The HALE programme will consist of: regular meetings in small
groups; short (5-10 min) instructor-led program of upper extremity stretching
exercises at the end of the meeting.
Study burden and risks
Each participant will benefit from the supplementary clinical measurements
performed during the study. Participants of the movement intervention group
will exercise with guidance of a professional. The participants of the
education group will receive relevant information regarding healthy aging
lifestyle.The main burden of the study is it*s duration of minimal 2 and
maximal 3 years and compliance to the research protocol. The risks of the study
are comparable with those of regular health care.
P Debyelaan 25
Maastricht 6202 AZ
NL
P Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
- Participants have to be willing to be randomised to either intervention group and to follow study protocol
- Men and women
- Aged 70 years and older
- SPPB score ranging between 3 (included) and 9 (included)
- Ability to complete 400-m walk test within 15 minutes without sitting down, the help of another person or the use of a walker
- Presence of low muscle mass according to results from a DXA scan and in agreement with the Foundation for the National Institutes of Health Sarcopenia Project (FNIH) reports.
Exclusion criteria
- Unable or unwilling to provide informed consent or accept randomisation in either study group
- 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
- Nursing-home residence
- Household member enrolled in the study
- Current diagnosis of schizophrenia, other psychotic or bipolar disorder
- Consumption of more than 14 alcoholic drinks per week
- Difficulty communicating with the study personnel due to speech, language, or (non-corrected) hearing problems
- MMSE lower than 24/30
- Severe arthritis (e.g., awaiting joint replacement) that would interfere with the ability to participate fully in either study arm
- 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)
- Lung disease requiring regular use of supplemental oxygen
- Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
- Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
- Upper and/or lower extremity amputation
- Peripheral arterial disease Lériche-Fontaine 3 or 4
- Parkinson*s disease or other progressive neurological disorder
- Renal disease requiring dialysis
- Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline 400-metre walk test
- Current participation in a structured PA program, physical therapy or cardiopulmonary rehabilitation
- Current enrolment in another RCT involving lifestyle, nutrition, or pharmaceutical interventions
- 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 MCI or the HALE programmes
- Other illness of such severity that life expectancy is expected to be less than 12 months
- Clinical judgment concerning safety or non-compliance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02582138 |
| CCMO | NL54645.068.15 |