PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY
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|ClinicalTrials.gov Identifier: NCT04072185|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
|First Submitted Date ICMJE||July 19, 2019|
|First Posted Date ICMJE||August 28, 2019|
|Last Update Posted Date||August 28, 2019|
|Actual Study Start Date ICMJE||September 15, 2018|
|Estimated Primary Completion Date||March 14, 2020 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY|
|Official Title ICMJE||CHANGES IN THE EMOTIONAL STATE, QUALITY OF LIFE AND SOCIAL SUPPORT AFTER A PROGRAM OF PHYSICAL ACTIVITY IN THE ELDERLY PEOPLE: RANDOMIZED MULTI-CENTER CLINICAL TRIAL|
Background: Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly of our society. This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these situations, since sometimes pharmacological options are limited in these patients. Physical activity (AF) and social relationships in the elderly are linked to physical and mental health. Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way, however, few studies have evaluated their effectiveness in our territory.
Design: Multicentre, randomized, two-group clinical trial, of 1 year follow-up. Study population: Patients over 64 years of age assigned to primary care teams (EAP) from different locations: Sant Joan de Vilatorrada, Súria and Manresa 2.
Inclusion criteria: To meet criteria of depression or anxiety at the time of the study, score> 12 on the Beck Depression Scale and / or score> 10 on the GAD-7 Scale (General Anxiety Disorder) and that Present a score <32 on the steps of DUKE-UNC-11.
A randomization of between 44 and 56 patients will be performed at each participant EAP. Half will be allocated to the control group (GC) and half to the intervention group (GI).
The intervention group will participate in a group AF program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.
. Main measures: Response to the intervention or clinical remission of depression (Escalera de Beck), and / or anxiety (Escala GAD-7), improvement of social support (DUKE-UNC) and quality of life (EuroQol) . Secondary measures: Adherence to the AF (VREM questionnaire (Spanish Reduced Version of the Minnesota Free Time Questionnaire in Minnesota)), and linkage to sociocultural entities once the intervention has been completed. The assessments will be made at 0, 4, 8 and 12 months.
BACKGROUND AND CURRENT STATUS OF THE SUBJECT:
In our society, thanks to medicine and development, the proportion of the elderly population tends to increase every year. The percentage of people over 64 years of age in 2017 in Spain was 18.8%, and is expected to continue to increase to 34.6% in 2066, according to the National Statistics Institute projection (1).
Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly in our society. As much in adult population as in old population noninstitutionalized it has been verified that to have little social support is related to a worse mental health. According to the European Health Survey in Spain carried out by the Ministry of Health, Consumption and Social Welfare of 2017, the prevalence of depression and chronic anxiety were in subjects of 65-74 years of 10.64% and 8.25% , from 75 to 84 years of 13.73% and 9.49% and over 85 years of 11.36% and 6.68% (2). This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these conditions, since sometimes pharmacological options are limited in these patients.
For decades it has been known that social relationships are linked to physical and mental health. A satisfying social network promotes healthy behaviors and habits. Social support especially protects the elderly from loneliness (3) and from depression (4). In particular, it can have a beneficial impact on mental health problems and psychological distress among older adults (5).
Also AF in the elderly has multiple advantages, not only at the physical level but also at the emotional level (6-8), several studies show that physical or leisure activities reduce loneliness (9), depression (10- 14), anxiety (15) and are associated with better mental health (16, 17). According to Guszkowska (18), the AF's benefits of anxiety, depression and irritability are especially high in those who start from high levels of anxiety and depression. The type of AF that causes major improvements is those based on cyclical aerobic activities (walking, swimming or cycling) from moderate to low intensity. This statement is aligned with the position of the American College of Sports Medicine, which recommends AF for the larger populations and affirms that regular AF can minimize the physiological and psychological effects of a sedentary lifestyle time that increases the expectations of life (19) and the quality of life (20). Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way (21), however, few studies in our territory have evaluated their effectiveness.
-To evaluate if the AF improves the emotional, social and quality of life situation in a sample of people over 64 years of age with problems of anxiety, depression and little social social support.
METHODOLOGY Design: Multicentre, randomized, two-group clinical trial, of 1 year follow-up. Study population: Patients over 64 years of age assigned to primary care teams (EAP) from different locations: Sant Joan de Vilatorrada (12,721 assigned), Súria (8,956 assigned), Manresa 2 (23,351 assigned). With this representativeness of territories, patients living in urban, semi-urban and rural areas will be able to study. Subsequently, the participation of other SAP teams will be attempted.
Inclusion criteria: Meet the criteria of depression or anxiety at the time of the study, score> 12 on the Beck Depression Scale (BDI-II) and / or score> 10 on the GAD-7 Scale (General Anxiety Disorder) and that they score <32 on the back of DUKE-UNC-11. Possibility to follow a year by the same primary care team. At least read and write Spanish or Catalan.
Exclusion criteria. Diagnosis of dementia or moderate cognitive impairment. Greater depression (BECK scale score> 28). Dependency disorders due to abuse of alcohol or other drugs. You are receiving some psychological therapy from the Center for Reference Mental Health. Physical illness at an advanced stage. Present any physical, mental or temporary limitations to be able to walk 1 hour a day two days a week. That they have not signed the informed consent.
Show and recruitment: Each participating Primary Care Team (EAP) will be randomized between 44 and 56 patients. Half will be allocated to the control group (GC) and half to the intervention group (GI). The recruitment will be consecutive in each EAP.
The professionals participating in the study will consult the database of the Computerized Clinical History of Catalonia (ECAP) through the consultation form of their quotas (Dbsform), in order to obtain the lists of patients that meet the inclusion criteria (have the active diagnosis of depression or anxiety and have little social support). Subsequently, your doctor or nurse will make the selection of the patients and will contact them to offer them the possibility to participate in the study and, in case they accept, they will be grouped in their CAP to explain In detail, study and sign informed consent, an interview will be followed and the questionnaires will be administered to assess whether they meet the inclusion criteria. They will finally be assigned to Control group or intervention randomly and anonymously using a statistical program.
Sample size: The sample size for independent groups was estimated, capable of detecting differences of two points in the average score of the Depression of Beck and GAD-7 and 7 points in the scale of social support of DUKE-UNC-11. A control has been assigned for each case, assuming a statistical power of 80% with a confidence interval of 95%. Between 146 and 162 patients would be needed and for reasons of convenience three groups of 50 patients each will form in each EAP, 25 of which will be in the intervention groups and 25 in the control units.
Variables and measurement methods:
Variables main results:
Secondary result variables:
Variables that can act as confusers or modifiers of the effect:
The intervention group will participate in a group AF program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. The sessions will be directed by two referents of each CAP, which will carry an application to the mobile (type STRAVA), to control the distances recurred from each session. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.
In the field work, different groups of professionals participate:
The external evaluator will be in charge of collecting the results of the self-administered scales previously mentioned in paper. These stairs will be in a unique place that only this reviewer will have access to. They will be read with automatic reading with the identifier of the survey using the Teleform Elite v 8.2 reading software.
Initially, the sociodemographic characteristics of the two groups will be described. For the description of qualitative variables, percentages and for quantitative, standard averages and averages, ranges and 25-75 percentiles will be used.
Previous to the intervention, baseline scores on the selected scales after randomization of the patients will be compared to verify that there are no significant differences. After the intervention, the average scores of the different scales in both groups will be compared independently, and for the different periods of post-intervention time, using the Student test for matched samples in case of normality adjustment or the Mann-Whitney U if the distribution was not normal. A secondary analysis, through multiple regression, will be carried out, including sociodemographic and confusing variables, for the variable of clinical remission of depression Yes / No (Yes: Beck scale <12), for the clinical remission variable of anxiety Yes / No (Yes: GAD-7 <10) and for the social support variable Yes / no (Yes: DUKE-UNC-11> 32).
The results showing differences with a p <0.05 will be considered significant. For statistical analysis, it was used in program SPSS v. 18.
In accordance with Law 14/2007 of July 3, of biomedical and human rights research (BOE of July 4, 2007), all recruited patients will be informed verbally and in writing of the objectives, methodology, tests and interventions that can be received if they participate in the study. It will be included to those who sign informed consent in writing. The document will be written in a language that the patient can understand. The protocol has been approved by the Ethical Committee of Clinical Investigation of the JGol Idiap. The researchers undertake to maintain the confidentiality of the data. If the effectiveness of the intervention is shown, the control group will receive the same group intervention once the study has finished.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicentre, randomized, two-group clinical trial, of 1 year follow-up.Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Other: Physical activity
TThe intervention group will participate in a group physical activity program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. The sessions will be directed by two referents of each primary care center. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||September 14, 2020|
|Estimated Primary Completion Date||March 14, 2020 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||65 Years and older (Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Spain|
|Removed Location Countries|
|NCT Number ICMJE||NCT04072185|
|Other Study ID Numbers ICMJE||CEI 19/031-P|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Jordi Gol i Gurina Foundation|
|Study Sponsor ICMJE||Jordi Gol i Gurina Foundation|
|Collaborators ICMJE||Institut Català de la Salut|
|PRS Account||Jordi Gol i Gurina Foundation|
|Verification Date||August 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP