Multimodal InterventionPowerA-01NCT02772952
Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial
A study testing Multimodal Intervention in people with Multimodal Intervention and Fragility, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Multimodal Intervention, Fragility, Other Metabolic Diseases
- What is being tested?
- Multimodal Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program
Who cannot join
- Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Multimodal Intervention, Fragility, Other Metabolic Diseases, Physical Activity, Patient Fall, Dietary Modification
- Being tested
- Control Intervention, Multimodal Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control InterventionOther
Control Intervention: review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles)
Multimodal InterventionOther
Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | 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) Receives: Other: Control Intervention |
| Experimental Group | Experimental | Experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program. Receives: Other: Multimodal Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
The measurements will be taken following the anthropometric parameter guidelines of The International Society for the Advancement of Kinanthropometry (ISAK) (Ross et al., 1978).
Measured: Baseline - 6 months after the end of the intervention
Health Related Quality of Life SF-12
General health condition was measured using the SF-12 short form questionnaire, adapted from the extended SF-36 version. Both physical and mental components are evaluated. The higher the score the better the condition. SF-12 reliability has proven a high internal consistency demonstrating an approximate ICC (Intraclass Correlation Coefficient) of 0.9. (Vigalut et al., 2008).
Measured: Baseline - 6 months after the end of the intervention
Fatigue State POMS (Profile of Mood States)
The Spanish version of POMS published by Andrade et al. (2010) was used, with 44 items that represented six conceptual dimensions: anger (11 items), fatigue (6 items), vigour (5 items), friendship (6 items), stress (7 items) and depressed state (9 items). As usual, the answer format consisted of a 5 ordered category response, assigned with values 0 (nothing) to 4 (a lot). All the items were put forward in the same trend except for the item 29-relaxed (corresponding to the state of stress) scores, that were inverted after the test.
Measured: Baseline - 6 months after the end of the intervention
Frailty Questionnaire
The auto-administrated survey based in 10 dichotomous questions in order to detect elder frail people will be carried out (Di Bari et al.2014).
Measured: Baseline - 6 months after the end of the intervention
MMSE (Mini-Mental State Examination) - MEC-30 (Mini Cognitive Examination
The MEC consists of 30 items grouped into 11 sections (Fig. 1), the clinician could carry out in 5-15 min based on the following indications; note that those responsible for carrying out this instrument, both in its original version (Folstein) and its Spanish adaptation (Lobo et al, 2002), warn that the professional should stick to these criteria as far as possible, ensuring maximum objectivity in registering the subject's responses. The eleven sections are: Orientation to time, Orientation to space, Registration, Attention and Calculation, Memory, Nomination, Repetition (Recall), Comprehension, Reading, Writing and Drawing.
Measured: Baseline - 6 months after the end of the intervention
Motor memory test
Motor skill memory and body awareness will be measured directing a test that consists of performing ten static positions. The examiner executes 10 positions holding each one of them for 10 seconds. Immediately after, the patient imitates the position in the opposite way, analogous to a mirror. The test ends when the 10 positions have been carried out. This test is included in the "Memory in movement" program, used as a cognitive intervention tool (Rey Cao, Canales Lacruz, Táboas País, \& Cancela Carra, 2008).
Measured: Baseline - 6 months after the end of the intervention
Spatial orientation test
The SODT-R (Spatial Orientation Dynamic Test-Revised, SODT-R, Colom, Contreras, Shih and Santacreu, 2003) task is to direct two moving objects to a given destination. There are two buttons for each of the moving objects in order to control their course, as shown in Figure 1. Pressing the buttons changes the object's course in one direction, reducing or increasing the angular discrepancy between the current course compared to the ideal course that would stand for 0 deviation.
Measured: Baseline - 6 months after the end of the intervention
Grip strength test
Hand grip strength test will examine the peak of strength and fatigue resistance. The test is performed with the participant in a sitting position and 90 degree elbow flexion, neutral pronosupination and flexion, extension or inclination of the wrist will not be allowed. The patient will be asked to hand grip, which will be evaluated with a hydraulic dynamometer JAMAR (Bellace, Healy, Besser, Byron, \& Hohman, 2000).
Measured: Baseline - 6 months after the end of the intervention
Balance (static - semi-static and dynamic) test
Expanded TUG is a test to assess mobility, balance and risk of falls in the elderly. (Podsiadlo and Richardson, 2015). The test consists of timing how long the seated patient takes to get up, walk ten metres, return and sit back again on the chair.
Measured: Baseline - 6 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start1 Nov 2017
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multimodal InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Andaluz Health Service
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772952
- Sponsor's protocol ID
- Power-Aging-01
- Acronym
- PowerA-01
- Status last verified
- May 2019
- First submitted
- 2 Dec 2015
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31226936
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02772952
- Acronym / sponsor ID
- PowerA-01 / Power-Aging-01
- Conditions
- Multimodal Intervention, Fragility, Other Metabolic Diseases, Physical Activity, Patient Fall, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Andaluz Health Service
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Control Interventiona control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) |
| Experimental Group | Experimental | Other: Multimodal InterventionExperimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program
Key exclusion criteria (1 listed)
- Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control InterventionControl Intervention: review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) | Other | Control Group |
| Multimodal InterventionMultimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program | Other | Experimental Group |
Primary outcome
Body mass index
Time frame: Baseline - 6 months after the end of the intervention
The measurements will be taken following the anthropometric parameter guidelines of The International Society for the Advancement of Kinanthropometry (ISAK) (Ross et al., 1978).
Health Related Quality of Life SF-12
Time frame: Baseline - 6 months after the end of the intervention
General health condition was measured using the SF-12 short form questionnaire, adapted from the extended SF-36 version. Both physical and mental components are evaluated. The higher the score the better the condition. SF-12 reliability has proven a high internal consistency demonstrating an approximate ICC (Intraclass Correlation Coefficient) of 0.9. (Vigalut et al., 2008).
Fatigue State POMS (Profile of Mood States)
Time frame: Baseline - 6 months after the end of the intervention
The Spanish version of POMS published by Andrade et al. (2010) was used, with 44 items that represented six conceptual dimensions: anger (11 items), fatigue (6 items), vigour (5 items), friendship (6 items), stress (7 items) and depressed state (9 items). As usual, the answer format consisted of a 5 ordered category response, assigned with values 0 (nothing) to 4 (a lot). All the items were put forward in the same trend except for the item 29-relaxed (corresponding to the state of stress) scores, that were inverted after the test.
Frailty Questionnaire
Time frame: Baseline - 6 months after the end of the intervention
The auto-administrated survey based in 10 dichotomous questions in order to detect elder frail people will be carried out (Di Bari et al.2014).
MMSE (Mini-Mental State Examination) - MEC-30 (Mini Cognitive Examination
Time frame: Baseline - 6 months after the end of the intervention
The MEC consists of 30 items grouped into 11 sections (Fig. 1), the clinician could carry out in 5-15 min based on the following indications; note that those responsible for carrying out this instrument, both in its original version (Folstein) and its Spanish adaptation (Lobo et al, 2002), warn that the professional should stick to these criteria as far as possible, ensuring maximum objectivity in registering the subject's responses. The eleven sections are: Orientation to time, Orientation to space, Registration, Attention and Calculation, Memory, Nomination, Repetition (Recall), Comprehension, Reading, Writing and Drawing.
Motor memory test
Time frame: Baseline - 6 months after the end of the intervention
Motor skill memory and body awareness will be measured directing a test that consists of performing ten static positions. The examiner executes 10 positions holding each one of them for 10 seconds. Immediately after, the patient imitates the position in the opposite way, analogous to a mirror. The test ends when the 10 positions have been carried out. This test is included in the "Memory in movement" program, used as a cognitive intervention tool (Rey Cao, Canales Lacruz, Táboas País, \& Cancela Carra, 2008).
Spatial orientation test
Time frame: Baseline - 6 months after the end of the intervention
The SODT-R (Spatial Orientation Dynamic Test-Revised, SODT-R, Colom, Contreras, Shih and Santacreu, 2003) task is to direct two moving objects to a given destination. There are two buttons for each of the moving objects in order to control their course, as shown in Figure 1. Pressing the buttons changes the object's course in one direction, reducing or increasing the angular discrepancy between the current course compared to the ideal course that would stand for 0 deviation.
Grip strength test
Time frame: Baseline - 6 months after the end of the intervention
Hand grip strength test will examine the peak of strength and fatigue resistance. The test is performed with the participant in a sitting position and 90 degree elbow flexion, neutral pronosupination and flexion, extension or inclination of the wrist will not be allowed. The patient will be asked to hand grip, which will be evaluated with a hydraulic dynamometer JAMAR (Bellace, Healy, Besser, Byron, \& Hohman, 2000).
Balance (static - semi-static and dynamic) test
Time frame: Baseline - 6 months after the end of the intervention
Expanded TUG is a test to assess mobility, balance and risk of falls in the elderly. (Podsiadlo and Richardson, 2015). The test consists of timing how long the seated patient takes to get up, walk ten metres, return and sit back again on the chair.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 31226936Gonzalez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Intervention in people with Multimodal Intervention and Fragility, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: Baseline - 6 months after the end of the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.