An interventional study of verbal guidance and a booklet in Physical Activity, Hospitalization and Aged, sponsored by Universidade Cidade de Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Prevention
Among 350 studies in Motor Activity with a site in Brazil — 41 open to participants now, 52 under way, none of them phase 3. Motor Activity · Brazil.
Among the 350 studies in Motor Activity with a site in Brazil, this one is the 91st largest by enrollment of the 328 interventional ones that give a count, is one of 38 that started in 2017, is one of 296 with no phase, and was the 185th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →41 of the 350 studies in Motor Activity with a site in Brazil are open now. Recruiting first, the newest first:
São Paulo State University · Sites in Brazil
Federal University of Jatai · Sites in Brazil
Universidade Estadual do Norte do Parana · Sites in Brazil
Universidade Federal do Paraná · Sites in Brazil
Hospital de Clinicas de Porto Alegre · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
350 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 5 · Phase 3 12 · Phase 4 9
First in 1999; this study’s year is marked. 38 started in 2017.
This study's enrollment of 68 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 44 across the 328 interventional studies, 97 across the 22 observational. Of the 214 that completed or were terminated, 12 (6%) have results posted.
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3 of 350 have an industry lead sponsor. The 10 most frequent:
Universidade Cidade de Sao Paulo is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
Universidade Cidade de Sao Paulo has 4 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
13 of the studies in Motor Activity with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07730255University of Sao PauloExercise and Taurine Supplementation on Intramuscular Fat in Older Women With Obesity | 2026-12 |
| NCT07561359Hospital de Clinicas de Porto Alegre12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE) | 2026-12 |
| NCT07621523Universidade Estadual do Norte do ParanaEnergy Cost and Metabolic Intensity of Pilates Exercises in Older Adults | 2026-12 |
| NCT07155967Paulista UniversityEffect of Cross-Education in Blood Flow Restriction Resistance Training on Lower Limbs in Older Women | 2026-12-01 |
| NCT06636006Universidade Federal de GoiasAerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia | 2026-12-30 |
Among the 350 studies in Motor Activity with a site in Brazil, from their registry updates:
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Introduction: The level of physical activity decreases progressively with age. Elderly subjects who are physically active have lower rates of morbidity and mortality when compared to those inactive. Hospitalization leads to long periods of bed rest and physical inactivity, with consequent muscle atrophy, generalized weakness, and decreased independence and functionality. Therefore, preventing inactivity, loss of muscle strength and the worsening of functional performance during hospitalization may be a way to avoid loss of independence. And while movement has been increasingly promoted as an important part of the recovery of hospitalized patients, many of them still spend much of the time bedridden while in hospital. Objectives: To evaluate the impact of a guiding program on the importance of remaining active during hospitalization in relation to the level of physical activity, functionality and muscular strength of elderly patients and to identify the main barriers that impede them to perform physical activities in the hospital environment. Methods: Randomized and controlled trial which will include elderly patients admitted to the Respiratory Diseases and Medical Clinic wards of the Institute of Medical Assistance to State Public Servants, in São Paulo. The intervention group will receive verbal guidelines and one booklet on the deleterious effects of hospitalization and the importance of staying active during hospitalization. All patients will be evaluated through accelerometry to identify the level of physical activity during hospitalization. Functionality will be evaluated through the DEMMI scale, muscular strength through handgrip and the main barriers to stay active during hospitalization by applying a questionnaire. The days of hospitalization and the clinical complications presented by the patients during the stay in the hospital will be noted. The difference of the outcomes of the level of physical activity and functionality before and after the intervention will be compared between the control and the intervention group through a t-test. The length of hospital stay will be analyzed by the Kaplan-Meier test and the incidence of complications by the chi-square test.
Experimental Design: Patients located during the study period and who meet the eligibility criteria will be invited to participate and, after signing the informed consent form, will be evaluated for anthropometric and clinical characteristics. At this moment, patients will be randomized into two groups: intervention and control. The intervention group will receive verbal guidance and a booklet developed by the authors on the deleterious effects of hospitalization and the importance of staying active during hospital admission on the day they are included in the study. The control group will not receive any type of intervention, nor even verbal guidance. Patients from both groups will have an accelerometer placed on the wrist in the dominant limb, which should only be removed at hospital discharge. Besides the level of physical activity, patients will be evaluated for functionality, peripheral muscle strength, length of hospital stay, and incidence of complications during the hospitalization period. The researchers will contact the patients via telephone within 72 hours after hospital discharge in order to apply a questionnaire for identification of the main barriers to stay active during hospitalization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
verbal guidance and a booklet on the importance and benefits of movement during hospital stay, as well as what the patients should do to increase the level of physical activity.
Behavioral: verbal guidance and a booklet
The control group will not receive any type of intervention
Patients allocated to the intervention group will receive verbal instruction from the researchers on the importance and benefits of movement during hospital stay, as well as what they should do to increase the level of physical activity. These patients will receive the same guidelines through a playable, easy-to-understand and inexpensive booklet developed by the researchers themselves in PowerPoint 2016 (Microsoft) in order to remedy any doubt or forgetfulness during the hospitalization period
Level of physical activity
This variable will be evaluated by means of accelerometry using the an ActiGraph accelerometer (Actigraph Inc, USA) placed on the wrist of the patient's dominant limb in the first 48 h of admission. The calibration will be performed 24 hours a day, during the entire period of hospitalization, and will be removed only at the moment of hospital discharge. The equipment is waterproof, so there is no need to remove it for bath or personal hygiene, and its battery lasts up to 20 days of consecutive collection. The Actigraph GT3X records the number of steps, the time in different body positions, the intensity of movements and predicts the metabolic rate
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Functionality
The evaluation of functionality will be done by applying the Morton Mobility Index (DEMMI). The DEMMI is a validated scale for elderly individuals during hospitalization and evaluates 15 activities divided into 5 groups: activities in bed, in the chair, static balance, ambulation and dynamic balance. The examiner's evaluation consists in punctuating the performance of the elderly in each of the motor conditions with scores varying from 0.1 to 2 points, resulting in a maximum score of 19 points. A conversion table allows the transformation of the raw score into a specific scale score, called DEMMI scores, ranging from 0 to 100 points, with higher scores indicating a higher level of mobility. The DEMMI scale consists of a paper sheet to be filled with a ballpoint pen, with printed articles on one side and the instruction protocol on the other, which makes it easy to use in clinical practice.
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Peripheral Muscular Strength
This will be evaluated after inclusion of the patient in the study and at the time of hospital discharge by a handgrip dynamometer (Smedley, Sahean, Belgium). The examiner will position the patient sitting and reclining comfortably in a chair with his feet flat on the floor. The dominant upper limb of the patient should maintain a 90-degree flexion without support and forearm in a neutral position. The unexamined upper limb will be resting, with the hand resting on the thigh. The patient will be asked to perform the manual grip movement. This movement will be repeated three times, with one-minute rest between attempts. The average of the three attempts will be adopted, which will be analyzed in its absolute value and in the reference value previously described for the Brazilian population.
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Length of hospital stay
It will be counted from admission to the ward until discharge
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of complications
These will be checked until the day of discharge through the records of a doctor who will be blind to the group to which the patient belongs. Clinical complications, specifically the appearance of a new health condition during hospitalization will be reported.
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Barriers to stay active during hospitalization
These will be evaluated within 72 hours after hospital discharge. A questionnaire developed by the researchers themselves and evaluated by specialists (physical therapists who work in the hospital area with more than five years of experience) will be applied via telephone contact. The questionnaire is composed of 16 dichotomous questions with "yes" or "no" answers. The questions concern the presented symptoms and the patient, the knowledge about the importance of the physical activity and the hospital. After the creation of the questionnaire, this was subjected to an evaluation of pertinence and understanding of the questions by 30 physical therapists who work in the hospital area and have at least 5 years of experience. All suggested modifications were accepted and the questionnaire will be applied to the patients.
Time frame: 72 hours after hospital discharge
Number of Physiotherapy sessions
The number of physiotherapy sessions received by the patient during the hospitalization period will be counted through the physiotherapeutic evolutions.
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days
Plan to share: No
Ran from Sep 2017 to primary completion in Sep 2018, 12 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 12 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Universidade Cidade de Sao Paulo