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Trial record 13 of 655 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases

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ClinicalTrials.gov Identifier: NCT03030547
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Fatma Ayvat, Hacettepe University

January 15, 2017
January 25, 2017
October 17, 2017
March 2016
October 2017   (Final data collection date for primary outcome measure)
  • Energy expenditure on SenseWear Activity Monitor [ Time Frame: 5 days ]
    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).
  • Number of steps on SenseWear Activity Monitor [ Time Frame: 5 days ]
    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.
Same as current
Complete list of historical versions of study NCT03030547 on ClinicalTrials.gov Archive Site
  • International Physical Activity Scale (IPAQ) [ Time Frame: 10 minutes ]
    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.
  • Visual Analog Scale [ Time Frame: 2 minutes ]
    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.
  • Fatigue Severity Scale [ Time Frame: 5 minutes ]
    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.
  • ACTIVLIM questionaire [ Time Frame: 5 minutes ]
    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.
  • Medical Outcomes Short-Form Health Survey [ Time Frame: 10 minutes ]
    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.
  • Hand Held Dynamometry [ Time Frame: 20 minutes ]
    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.
  • Six Minutes Walk Test [ Time Frame: 10 minutes ]
    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.
  • Timed Up and Go Test [ Time Frame: 2 minutes ]
    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.
Same as current
Not Provided
Not Provided
 
Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases
Erişkin Kas hastalıklarında Fiziksel Aktivite Ile ilişkili faktörlerin Belirlenmesi
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Muscle Disease
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).
  • Experimental: Muscle Disease Group
    Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days
    Intervention: Device: SenseWear activity monitor
  • Active Comparator: Healthy Individuals Group
    Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days
    Intervention: Device: SenseWear activity monitor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Same as current
October 2017
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of muscle diseases
  • Adult patients with muscle diseases who are able to walk independently

Exclusion Criteria:

  • Clinical diagnosis of systemic problems
  • Any orthopedic problems that will affect the performance of the physical activity
  • Clinical diagnosis of neurological disease other than muscle disease
  • Clinical diagnosis of cognitive impairment
  • Individuals who underwent surgery in the last 6 month
Sexes Eligible for Study: All
20 Years to 40 Years   (Adult)
Yes
Contact: Fatma Ayvat, Msc +903123051572 ext 183 fatma.avcu@hacettepe.edu.tr
Contact: Muhammed Kılınç, Assoc Prof +903123051572 ext 163 muhammedkilinc@yahoo.com
Turkey
 
 
NCT03030547
GO 14/617
No
Not Provided
Plan to Share IPD: No
Fatma Ayvat, Hacettepe University
Hacettepe University
Not Provided
Principal Investigator: Fatma Ayvat, Msc Hacettepe University
Principal Investigator: Muhammed Kılınç, Assoc Prof Hacettepe University
Study Director: Sibel Aksu Yıldırım, Prof Hacettepe University
Hacettepe University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP