- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327975
Prescription of Physical Exercise Through Mobile Application in Elderly (PEME)
Effects of a Training Program of Physical Exercise Administered Through Mobile Application in Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives of the study:
- Evaluate effectiveness of a physical exercise program for 10 weeks to improve fitness, cardiovascular, anthropometric and body composition parameters in people over 53 years.
- Examine effects of exercise intervention delivered through a mobile application (WhatsApp) on fitness, cardiovascular risk factors, anthropometric and body composition in people over 53 years.
Hypotheses of the study:
- An intervention of exercise administered via mobile application (WhatsApp) is effective in reducing cardiovascular risk factors in people over 53 years.
- An intervention of exercise administered via mobile application (WhatsApp) is effective to increase physical fitness in people over 53 years.
- An intervention of exercise administered via mobile application (WhatsApp) is effective in reducing BMI, percent body fat; and in increasing the percentage of muscle mass in people over 53 years.
- 10-weeks face-to-face intervention of physical exercise obtains greater improvements in fitness parameters than an intervention delivered via mobile application in people over 53 years.
- 10-weeks face-to-face intervention of physical exercise obtains greater improvements in anthropometric and body composition than an intervention delivered via mobile application in people over 53 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Balearic Islands
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Majorca, Balearic Islands, Spain, 07122
- Josep Vidal Conti
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have own mobile phone and Internet
- Be clinically stable
- Be able to perform physical activity
- Be able to understand and complete the informed consent
- Ability to cope assessment tests
Exclusion Criteria:
- Unable to perform physical activity
- Have an acute or chronic disease
- Have medical conditions or other physical problem that needs special attention (history of fracture of any upper or lower limb, dementia, psychological problems, neuromuscular disease, history of myocardial infarction, osteoporosis, cancer, diabetes).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training group
Participants in this group received twice-weekly non-consecutive sessions of physical exercise for 10 weeks.
Each session lasted approximately 60-70 minutes.
Exercise program consisted of strength training and aerobic exercise.
Each session began with a warm low intensity (10 min), then the main part of the session (25 min) and aerobic training and recovery period (25-35 min) was performed.
The equipment used during the procedure was the Thera-Band elastic band.
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The main part of the session included a whole-body strength training, which incorporated chest press, shoulder press, lateral pull-down, seated row, shoulder flexion, chest pulley, hammer curl, biceps curl, triceps curl, triceps pushdown, leg extension, leg curl, lunge, squat, abdominal crunch. To control and equate the intensity between the TG and MG, a method based on the combined use of the prescribed number of repetitions and the OMNI Resistance Scale for the active muscles was used. Previous studies have described the method used for controlling exercise intensity (Colado et al., 2012; Colado et al., 2014). During 1-3 weeks subjects performed 25 min of exercise at 60% maximum heart rate (HRmax), during weeks 4-6 subjects performed 30 min of exercise at 70% HRmax and during weeks 7-10 subjects performed 35 min of exercise at 80% HRmax. |
Experimental: Mobile group
Intervention content was the same in both intervention arms; only the delivery mode differed.
Participants in this group received two podcast (digital multimedia file available for download in a media player) per week for 10 weeks of the intervention, each podcast lasted about 5 min.
Participants in this group received a weekly message with the aim of fostering motivation toward physical activity.
Subjects in this group performed two sessions per week on non-consecutive days, the days could be chosen by the participants themselves.
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The subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp).
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Other: Control group
No received intervention.
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No received intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Maximum hand grip strength (dynamometry)
Time Frame: Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks
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The manual pressure force was measured with a digital force gauge (TKK 5001 Grip-A; Takey, Tokyo, Japan) and the results are recorded in kilograms
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Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks
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Change from Baseline in Aerobic capacity
Time Frame: Change from Baseline in Aerobic capacity at 10 weeks
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Aerobic capacity was measured using 2-Minute Step Test.
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Change from Baseline in Aerobic capacity at 10 weeks
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Change from Baseline in Static Balance
Time Frame: Change from Baseline in Static Balance at 10 weeks
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Static balance measurement was conducted using the Flamingo test (Committee of Experts on Sport Research, 1988).
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Change from Baseline in Static Balance at 10 weeks
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Change from Baseline in Waist circumference
Time Frame: Change from Baseline in Waist circumference at 10 weeks
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Change from Baseline in Waist circumference at 10 weeks
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Change from Baseline in Body fat
Time Frame: Change from Baseline in Body fat at 10 weeks
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Body fat was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
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Change from Baseline in Body fat at 10 weeks
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Change from Baseline in Muscle mass
Time Frame: Change from Baseline in Muscle mass at 10 weeks
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Muscle mass was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
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Change from Baseline in Muscle mass at 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Physical activity levels
Time Frame: Change from Baseline in Physical activity levels at 10 weeks
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To measure levels of physical activity of the participants used the International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
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Change from Baseline in Physical activity levels at 10 weeks
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Change from Baseline in Height
Time Frame: Change from Baseline in Height at 10 weeks
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The height was measured as close to the millimeter using the mobile rod (Seca 217).
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Change from Baseline in Height at 10 weeks
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Change from Baseline in Weight
Time Frame: Change from Baseline in Weight at 10 weeks
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The weight was measured using bioelectrical impedance scales (Tanita Body Fat Monitor Scale plus, Model BF-556).
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Change from Baseline in Weight at 10 weeks
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Change from Baseline in Systolic Blood Pressure
Time Frame: Change from Baseline in Systolic Blood Pressure at 10 weeks
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The Systolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)
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Change from Baseline in Systolic Blood Pressure at 10 weeks
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Change from Baseline in Dyastolic Blood Pressure
Time Frame: Change from Baseline in Dyastolic Blood Pressure at 10 weeks
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The Dyastolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)
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Change from Baseline in Dyastolic Blood Pressure at 10 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Josep Vidal Conti, University of Balearic Islands
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- I+D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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