Clinical trial NCT04600453: Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program
Official title: Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Disability Physical
Hospital Acquired Condition
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
name: Complejo Hospitalario de Navarra
First posted: 2020-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hospitalized elderly patient is conditioned by a series of circumstances unrelated to the pathological process itself that caused hospital admission and that usually worsen the results of hospitalization. In fact, the implementation of care models different from the traditional ones has shown a clear benefit in the functional results of these patients in the short and medium term. However, the components of these models that explain these better results have not been differentially evaluated. Some examples of these circumstances are the usual orders of absolute rest without any objective criteria for patients who are able to wander, the perpetuation of continuous fluid therapy, physical and chemical restraints, unnecessary permanent probes, etc. On numerous occasions, hospitalized elderly patients spend most of their time in bed, reaching even more than 83% of bedridden compared to 4% of those who stand up or are walking. The average time that a geriatric patient walks during their hospitalization ranges from 7 to 43 minutes/day. This population, by having their functional and physiological reserve reduced, are more vulnerable to the effects, for example, of bedridden, which range from functional loss or cognitive impairment, to longer stays, mortality and institutionalization, worse emotional situation, delirium, deconditioning, aspirations, pressure ulcers, and falls, decreased caloric intake, social isolation, poorer quality of life, and greater use of health-related resources. This study is a multicenter randomized clinical trial to be conducted in the acute care for elderly (ACE) units of three tertiary hospitals in Spain - Complejo Hospitalario de Navarra (CHN), Hospital Central de la Cruz Roja de Madrid (HCCRM) and Complejo Hospitalario Universitario of Albacete (CHUA). After randomization, the research team (physiotherapist, sport science specialist and geriatrician) will together perform the baseline measurement and follow-up visits of functional, pharmacological, comorbidity and cognitive assessment, as well as of mobility and strength evaluations. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).


Eligibility criteria: Inclusion Criteria:

* \> 75 years
* Barthel Index ≥60 points
* Able to ambulate (with/without assistance)
* Sing the informed consent
* Able to communicate

Exclusion Criteria:

* Expected length of stay \<6 days
* Terminal illness
* Very severe cognitive decline (i.e., GDS 7)
* Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.

Primary outcomes:
measure: Rate of patients with change in functional and cognitive status
timeFrame: 3 years
Secondary outcomes:
measure: Rate of changes in the quality of life
timeFrame: 3 years
measure: Number of patients with delirium
timeFrame: 3 years
measure: Mortality Rate
timeFrame: 3 years
measure: Total use of health-related resources
timeFrame: 3 years
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra. Department of Geriatrics
state: Navarra
Study officials:
References: