Skip to main content
Clinical Trials/NCT04600453
NCT04600453
Completed
Not Applicable

Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial

Fundacion Miguel Servet1 site in 1 country200 target enrollmentMay 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Fundacion Miguel Servet
Enrollment
200
Locations
1
Primary Endpoint
Rate of patients with change in functional and cognitive status
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 10, 2018
End Date
June 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacion Miguel Servet
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Rate of patients with change in functional and cognitive status

Time Frame: 3 years

The functional capacity of participants will be evaluated by the Short Physical Performance Battery (SPPB), the total score ranging from 0 (worst) to 12 points (best) which includes balance, gait and rising from a chair test. Standing balance test consists in the ability to maintain the standing position for 10s with three different foot position: parallel, semi-tandem and tandem. Walking speed measure, the time needed to progress for 4 linear meters with patient's usual speed, assigning a different score according to speed. Chair sit-to-stand assesses the ability to stand from a chair 5 consecutive times without using arms. The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality.

Secondary Outcomes

  • Rate of changes in the quality of life(3 years)
  • Mortality Rate(3 years)
  • Total use of health-related resources(3 years)
  • Number of patients with delirium(3 years)

Study Sites (1)

Loading locations...

Similar Trials