Clinical trial NCT03030547: Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases
Official title: Erişkin Kas hastalıklarında Fiziksel Aktivite Ile ilişkili faktörlerin Belirlenmesi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Energy expenditure on SenseWear Activity Monitor
timeFrame: 5 days
measure: Number of steps on SenseWear Activity Monitor
timeFrame: 5 days
Secondary outcomes:
measure: International Physical Activity Scale (IPAQ)
timeFrame: 10 minutes
measure: Visual Analog Scale
timeFrame: 2 minutes
measure: Fatigue Severity Scale
timeFrame: 5 minutes
measure: ACTIVLIM questionaire
timeFrame: 5 minutes
measure: Medical Outcomes Short-Form Health Survey
timeFrame: 10 minutes
measure: Hand Held Dynamometry
timeFrame: 20 minutes
measure: Six Minutes Walk Test
timeFrame: 10 minutes
measure: Timed Up and Go Test
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences
Study officials:
affiliation: Hacettepe University
name: Fatma Ayvat, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Muhammed Kılınç, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Sibel Aksu Yıldırım, Prof
role: STUDY_DIRECTOR
References:
citation: McDonald CM. Physical activity, health impairments, and disability in neuromuscular disease. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S108-20. doi: 10.1097/00002060-200211001-00012.
citation: McCrory MA, Kim HR, Wright NC, Lovelady CA, Aitkens S, Kilmer DD. Energy expenditure, physical activity, and body composition of ambulatory adults with hereditary neuromuscular disease. Am J Clin Nutr. 1998 Jun;67(6):1162-9. doi: 10.1093/ajcn/67.6.1162.
citation: Kilmer DD, Wright NC, Aitkens S. Impact of a home-based activity and dietary intervention in people with slowly progressive neuromuscular diseases. Arch Phys Med Rehabil. 2005 Nov;86(11):2150-6. doi: 10.1016/j.apmr.2005.07.288.
citation: Mulligan HF, Hale LA, Whitehead L, Baxter GD. Barriers to physical activity for people with long-term neurological conditions: a review study. Adapt Phys Activ Q. 2012 Jul;29(3):243-65. doi: 10.1123/apaq.29.3.243.
citation: Scheers T, Philippaerts R, Lefevre J. Variability in physical activity patterns as measured by the SenseWear Armband: how many days are needed? Eur J Appl Physiol. 2012 May;112(5):1653-62. doi: 10.1007/s00421-011-2131-9. Epub 2011 Aug 28.
citation: Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
citation: Brinkmann JR. Comparison of a hand-held and fixed dynamometer in measuring strength of patients with neuromuscular disease. J Orthop Sports Phys Ther. 1994 Feb;19(2):100-4. doi: 10.2519/jospt.1994.19.2.100.
citation: Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
citation: Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.
citation: Vandervelde L, Van den Bergh PY, Goemans N, Thonnard JL. ACTIVLIM: a Rasch-built measure of activity limitations in children and adults with neuromuscular disorders. Neuromuscul Disord. 2007 Jun;17(6):459-69. doi: 10.1016/j.nmd.2007.02.013. Epub 2007 Apr 11.
citation: Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.