NCT02327975

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

December 20, 2014

Last Update Submit

February 27, 2015

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • Change from Baseline in Aerobic capacity

    Aerobic capacity was measured using 2-Minute Step Test.

    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).

    Change from Baseline in Static Balance at 10 weeks

  • Change from Baseline in Waist circumference

    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

    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

    Change from Baseline in Muscle mass at 10 weeks

Secondary Outcomes (5)

  • Change from Baseline in Physical activity levels

    Change from Baseline in Physical activity levels at 10 weeks

  • Change from Baseline in Height

    Change from Baseline in Height at 10 weeks

  • Change from Baseline in Weight

    Change from Baseline in Weight at 10 weeks

  • Change from Baseline in Systolic Blood Pressure

    Change from Baseline in Systolic Blood Pressure at 10 weeks

  • Change from Baseline in Dyastolic Blood Pressure

    Change from Baseline in Dyastolic Blood Pressure at 10 weeks

Study Arms (3)

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.

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.

Other: Mobile group

Control group

OTHER

No received intervention.

Other: Control group

Interventions

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.

Training group

The subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp).

Mobile group

No received intervention.

Control group

Eligibility Criteria

Age53 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josep Vidal Conti

Majorca, Balearic Islands, 07122, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Sensitivity Training GroupsControl Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Josep Vidal Conti

    University of Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 31, 2014

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations