An interventional study of SenseWear activity monitor in Muscle Disease, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Hacettepe University · Not applicable, Interventional, and Other
To evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.
The same protocol will be applied all of the patients and healthy subjects. Individuals will be informed in detail about the study and demographic and physical properties will recorded after receiving approval. Evaluation programme that consisting of pain, fatigue, falls, activity limitations, quality of life, muscle strength assessment and functional assessment will be applied. After the evaluation, individuals will be given detailed information on the use of SenseWear activity monitors. Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity). Physical activity levels will be assessed by subjective aspects of physical activity questionnaire.
280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.
This study's enrollment of 80 is above the median of 34 across 157 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days
Device: SenseWear activity monitor
Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days
Device: SenseWear activity monitor
Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
Energy expenditure on SenseWear Activity Monitor
The SenseWear software calculates energy expenditure based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis as well as the various measurements (two-axis accelerometry, galvanic skin response, heat flux, skin and near-body temperature).
Time frame: 5 days
Number of steps on SenseWear Activity Monitor
The SenseWear software calculates number of steps based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis.
Time frame: 5 days
International Physical Activity Scale (IPAQ)
27 item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally. Duration (minutes) and frequency (days) of physical activity in the last 7 days is measured in domains of: Job-related, transportation, housework, house maintenance, caring for family, recreation, sport, leisure-time and time spent sitting. Overall score calculated using responses to all questions (Score is obtained by multiplying duration and frequency for each question) and total MET-min/week score obtained.
Time frame: 10 minutes
Visual Analog Scale
10 cm line anchored at both ends with words descriptive of the maximal and minimal extremes of the pain being measured. Individuals mark their pain intensity on a line numbered 0-10.
Time frame: 2 minutes
Fatigue Severity Scale
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Time frame: 5 minutes
ACTIVLIM questionaire
The ACTIVLIM questionnaire explores difficulties of performing daily activities that required the use of upper limbs or/and the use of lower limbs. The adult patients and the parents of affected children fill in either the adult form or the child form of the questionnaire. They are asked to provide their perceived difficulty in performing each activity using a three-level scale: impossible (0), difficult (1), easy (2). Each activity must be completed without technical or human assistance.
Time frame: 5 minutes
Medical Outcomes Short-Form Health Survey
The SF-36 is a generic patient-reported outcome measure aimed at quantifying health status, and is often used as a measure of health-related quality of life. The SF-36 is a 36-item questionnaire that measures the physical and mental health constructs of health status. These constructs are measured through 8 subscales. The physical component (PCS) is made up of physical functioning (PF), role-physical (RP), bodily pain (BP), and general health (GH). The Mental component (MCS) is made up of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (ME). Each of the 36 items is answered using a Likert-type scale and a 4-week recall period, with a total score of 0-100 possible. A higher score indicates better health status.
Time frame: 10 minutes
Hand Held Dynamometry
A quantitative and objective method for assessment of muscular strength using a portable hand held dynamometer. "Break Test" option is used in the study. "Break Test" where the tester applies a force to just overcome the strength of the person being tested, producing an eccentric muscular contraction and scored using force production in Newtons. 3 maximum voluntary isometric contractions are completed and scores summed.
Time frame: 20 minutes
Six Minutes Walk Test
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Walk of cover as far a distance as possible over 6 minute. Assistive devices can be used but kept consistent from test to test. Individual should be able to ambulate without physical assistance.
Time frame: 10 minutes
Timed Up and Go Test
Assesses mobility, balance, walking ability, and fall risk. The patient sits in the chair with his/her back against the chair back. On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated. Patient must use the same assistive device each time he/she is tested to be able to compare scores. 3 trials are completed and scores summed.
Time frame: 2 minutes
Plan to share: No
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Hacettepe University