Clinical trial NCT02772952: Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial
Official title: Effectiveness of a Multi-componentphysical Training Integrated Into a Multimodal Program Based on the Evidence in Hiper-fragile Elders: A Randomized Clinical Trial STUDY POWER_AGING
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimodal Intervention
Fragility
Other Metabolic Diseases
Physical Activity
Patient Fall
Dietary Modification
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2016-05-16
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare short-term and medium-term effectiveness of a multimodal program that integrates a program of therapeutic exercise, medication review, adequacy of diet and health education, compared with standard medical practice in improving neuromuscular and physiological status on frail elderly. Another aim is to analyze the maintenance of these effects by monitoring long-term (12 months) from the start of the intervention.

Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting inclusion / exclusion) will be randomized into two groups: a control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) and an experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program.

Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover, tracking variables will be collected at 2 and 6 months after starting the intervention and at 3 and 6 months after the end of the intervention (monitoring).

The monitoring variables that will be measured are: BMI , general health, fatigue, brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and metabolomic variables.

One descriptive analysis of the sociodemographic variables of the participants will be performed. Further the change on the variables intra-subjects (pre-post intervention) and inter-subjects (experimental group vs control group) will be calculated. For the intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject outcome variables will be compared between the two groups in each moments of data collection, using the student t-test or Wilconxon (depending of the sample distribution). The level of significance was set at P ≤ 0.05.


Eligibility criteria: Inclusion Criteria:

* People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program

Exclusion Criteria:

* Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.

Primary outcomes:
measure: Body mass index
timeFrame: Baseline - 6 months after the end of the intervention
measure: Health Related Quality of Life SF-12
timeFrame: Baseline - 6 months after the end of the intervention
measure: Fatigue State POMS (Profile of Mood States)
timeFrame: Baseline - 6 months after the end of the intervention
measure: Frailty Questionnaire
timeFrame: Baseline - 6 months after the end of the intervention
measure: MMSE (Mini-Mental State Examination) - MEC-30 (Mini Cognitive Examination
timeFrame: Baseline - 6 months after the end of the intervention
measure: Motor memory test
timeFrame: Baseline - 6 months after the end of the intervention
measure: Spatial orientation test
timeFrame: Baseline - 6 months after the end of the intervention
measure: Grip strength test
timeFrame: Baseline - 6 months after the end of the intervention
measure: Balance (static - semi-static and dynamic) test
timeFrame: Baseline - 6 months after the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Antonio Cuesta-Vargas
Study officials:
References:
citation: Gonzalez-Sanchez M, Cuesta-Vargas AI, Del Mar Rodriguez Gonzalez M, Caro ED, Nunez GO, Galan-Mercant A, Belmonte JJB. Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol. BMC Geriatr. 2019 Jun 21;19(1):171. doi: 10.1186/s12877-019-1188-x.