Motor ActivityPEMENCT02327975
Prescription of Physical Exercise Through Mobile Application in Elderly
A study testing Training group and Mobile group in people with Motor Activity and Aerobic Exercise, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
Physical inactivity is a health problem that affects people worldwide and has been identified as the fourth largest risk factor for overall mortality (contributing to 6% of deaths globally). Many researchers have tried to increase physical activity (PA) levels through traditional methods without much success. Read more about this study
- Who is it for?
- Ages 53 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Aerobic Exercise, Mobile Applications
- What is being tested?
- Training group and Mobile group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Sep 2013
- 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 53 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Training Program of Physical Exercise Administered Through Mobile Application in Elderly
Physical inactivity is a health problem that affects people worldwide and has been identified as the fourth largest risk factor for overall mortality (contributing to 6% of deaths globally). Many researchers have tried to increase physical activity (PA) levels through traditional methods without much success. Thus, many researchers are turning to mobile technology as an emerging method for changing health behaviours.The study consists of a physical activity intervention through a mobile application in elderly. The study is a 3x2 model, in which the sample is distributed in three study groups (over 53 years) and were evaluated at 10 weeks from baseline.
Read the 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.
- Conditions
- Motor Activity, Aerobic Exercise, Mobile Applications, Aged, Prescriptions, Cell Phones
- Being tested
- Training group, Mobile group, Control group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupOther
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.
Mobile groupOther
The subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp).
Control groupOther
No received intervention.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | 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. Receives: Other: Training group |
| Mobile group | Experimental | 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. Receives: Other: Mobile group |
| Control group | Other | No received intervention. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Maximum hand grip strength (dynamometry)
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
Measured: Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks
Change from Baseline in Aerobic capacity
Aerobic capacity was measured using 2-Minute Step Test.
Measured: Change from Baseline in Aerobic capacity at 10 weeks
Change from Baseline in Static Balance
Static balance measurement was conducted using the Flamingo test (Committee of Experts on Sport Research, 1988).
Measured: Change from Baseline in Static Balance at 10 weeks
Change from Baseline in Waist circumference
Measured: Change from Baseline in Waist circumference at 10 weeks
Change from Baseline in Body fat
Body fat was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
Measured: Change from Baseline in Body fat at 10 weeks
Change from Baseline in Muscle mass
Muscle mass was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
Measured: Change from Baseline in Muscle mass at 10 weeks
Secondary outcomes (5)
Change from Baseline in Physical activity levels
To measure levels of physical activity of the participants used the International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
Measured: Change from Baseline in Physical activity levels at 10 weeks
Change from Baseline in Height
The height was measured as close to the millimeter using the mobile rod (Seca 217).
Measured: Change from Baseline in Height at 10 weeks
Change from Baseline in Weight
The weight was measured using bioelectrical impedance scales (Tanita Body Fat Monitor Scale plus, Model BF-556).
Measured: Change from Baseline in Weight at 10 weeks
Change from Baseline in Systolic Blood Pressure
The Systolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)
Measured: Change from Baseline in Systolic Blood Pressure at 10 weeks
Change from Baseline in Dyastolic Blood Pressure
The Dyastolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)
Measured: Change from Baseline in Dyastolic Blood Pressure at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2013
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 Motor ActivityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep1, University of the Balearic Islands
- Investigators
- Josep Vidal Conti, Principal investigator, University of Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327975
- Sponsor's protocol ID
- I+D
- Acronym
- PEME
- Status last verified
- Feb 2015
- First submitted
- 20 Dec 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Muntaner-Mas A, Vidal-Conti J, Borras PA, Ortega FB, Palou P. Effects of a Whatsapp-delivered physical activity intervention to enhance health-related physical fitness components and cardiovascular disease risk factors in older adults. J Sports Med Phys Fitness. 2017 Jan-Feb;57(1-2):90-102. doi: 10.23736/S0022-4707.16.05918-1. Epub 2015 Sep 11.
PubMed 26364690
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Training Program of Physical Exercise Administered Through Mobile Application in Elderly
- ClinicalTrials.gov ID
- NCT02327975
- Acronym / sponsor ID
- PEME / I+D
- Conditions
- Motor Activity, Aerobic Exercise, Mobile Applications, Aged, Prescriptions, Cell Phones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- First posted
- 31 Dec 2014 (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.
Physical inactivity is a health problem that affects people worldwide and has been identified as the fourth largest risk factor for overall mortality (contributing to 6% of deaths globally). Many researchers have tried to increase physical activity (PA) levels through traditional methods without much success. Thus, many researchers are turning to mobile technology as an emerging method for changing health behaviours.The study consists of a physical activity intervention through a mobile application in elderly. The study is a 3x2 model, in which the sample is distributed in three study groups (over 53 years) and were evaluated at 10 weeks from baseline.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Training groupParticipants 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. |
| Mobile group | Experimental | Other: Mobile groupIntervention 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. |
| Control group | Other | Other: Control groupNo received intervention. |
Who may qualify
- Ages
- 53 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Training groupThe 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. | Other | Training group |
| Mobile groupThe subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp). | Other | Mobile group |
| Control groupNo received intervention. | Other | Control group |
Primary outcome
Change from Baseline in Maximum hand grip strength (dynamometry)
Time frame: Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks
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
Change from Baseline in Aerobic capacity
Time frame: Change from Baseline in Aerobic capacity at 10 weeks
Aerobic capacity was measured using 2-Minute Step Test.
Change from Baseline in Static Balance
Time frame: Change from Baseline in Static Balance at 10 weeks
Static balance measurement was conducted using the Flamingo test (Committee of Experts on Sport Research, 1988).
Change from Baseline in Waist circumference
Time frame: Change from Baseline in Waist circumference at 10 weeks
Change from Baseline in Body fat
Time frame: Change from Baseline in Body fat at 10 weeks
Body fat was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
Change from Baseline in Muscle mass
Time frame: Change from Baseline in Muscle mass at 10 weeks
Muscle mass was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used
5 secondary outcomes
Change from Baseline in Physical activity levels
Time frame: Change from Baseline in Physical activity levels at 10 weeks
Change from Baseline in Height
Time frame: Change from Baseline in Height at 10 weeks
Change from Baseline in Weight
Time frame: Change from Baseline in Weight at 10 weeks
Change from Baseline in Systolic Blood Pressure
Time frame: Change from Baseline in Systolic Blood Pressure at 10 weeks
Change from Baseline in Dyastolic Blood Pressure
Time frame: Change from Baseline in Dyastolic Blood Pressure at 10 weeks
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 3 Mar 2015.
- Derived from this study: PubMed 26364690Muntaner-Mas A, Vidal-Conti J, Borras PA, Ortega FB, Palou P. Effects of a Whatsapp-delivered physical activity intervention to enhance health-related physical fitness components and cardiovascular disease risk factors in older adults. J Sports Med Phys Fitness. 2017 Jan-Feb;57(1-2):90-102. doi: 10.23736/S0022-4707.16.05918-1. Epub 2015 Sep 11.
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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.
Josep Vidal Conti principal investigator
University of Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training group and Mobile group in people with Motor Activity and Aerobic Exercise, run by University of the Balearic Islands 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 5 inclusion and 3 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 3 Mar 2015. 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?
Change from Baseline in Maximum hand grip strength (dynamometry) (time frame: Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks). The study lists 6 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 NCT02327975, 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 3 Mar 2015.