Prescription of Physical Exercise Through Mobile Application in Elderly

Aged Clinical Trial

— PEME  

Official title:

Effects of a Training Program of Physical Exercise Administered Through Mobile Application in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327975
• Other study ID #: I+D
• Status: Completed
• Phase: N/A
• First received: December 20, 2014
• Last updated: February 27, 2015
• Start date: November 2012

Study information

• Verified date: February 2015
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 53 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aerobic Exercise
• Aged
• Cell Phones
• Mobile Applications
• Motor Activity
• Muscle Strenght
• Prescriptions
• Resistance Training

Intervention

Other:
• Training group
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 group
The subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp).
• Control group
No received intervention.

Locations

Country	Name	City	State
Spain	Josep Vidal Conti	Majorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in Maximum hand grip strength (dynamometry) at 10 weeks	Yes
Primary	Change from Baseline in Aerobic capacity	Aerobic capacity was measured using 2-Minute Step Test.	Change from Baseline in Aerobic capacity at 10 weeks	Yes
Primary	Change from Baseline in Static Balance	Static balance measurement was conducted using the Flamingo test (Committee of Experts on Sport Research, 1988).	Change from Baseline in Static Balance at 10 weeks	Yes
Primary	Change from Baseline in Waist circumference		Change from Baseline in Waist circumference at 10 weeks	Yes
Primary	Change from Baseline in Body fat	Body fat was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used	Change from Baseline in Body fat at 10 weeks	Yes
Primary	Change from Baseline in Muscle mass	Muscle mass was measured using Bioimpedance scale (Tanita Body Fat Monitor Scale plus, Model BF-556) is used	Change from Baseline in Muscle mass at 10 weeks	Yes
Secondary	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)	Change from Baseline in Physical activity levels at 10 weeks	Yes
Secondary	Change from Baseline in Height	The height was measured as close to the millimeter using the mobile rod (Seca 217).	Change from Baseline in Height at 10 weeks	Yes
Secondary	Change from Baseline in Weight	The weight was measured using bioelectrical impedance scales (Tanita Body Fat Monitor Scale plus, Model BF-556).	Change from Baseline in Weight at 10 weeks	Yes
Secondary	Change from Baseline in Systolic Blood Pressure	The Systolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)	Change from Baseline in Systolic Blood Pressure at 10 weeks	Yes
Secondary	Change from Baseline in Dyastolic Blood Pressure	The Dyastolic Blood Pressure was measured using Omron Elite 7300W (Omron Healthcare Inc, Bannockburn, IL, USA)	Change from Baseline in Dyastolic Blood Pressure at 10 weeks	Yes