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

NCT03030547 | Completed

• 1 other identifier: GO 14/617
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  5 days

Secondary Outcomes (8)

• International Physical Activity Scale (IPAQ)

  10 minutes

• Visual Analog Scale

  2 minutes

• Fatigue Severity Scale

  5 minutes

• ACTIVLIM questionaire

  5 minutes

• Medical Outcomes Short-Form Health Survey

  10 minutes

Study Arms (2)

Muscle Disease Group

EXPERIMENTAL

Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days

Device: SenseWear activity monitor

Healthy Individuals Group

ACTIVE COMPARATOR

Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days

Device: SenseWear activity monitor

Interventions

SenseWear activity monitor DEVICE

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).

Healthy Individuals Group; Muscle Disease Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Health Sciences

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 12409816 RESULT

• 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.

  PMID: 9625089 RESULT

• 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.

  PMID: 16271563 RESULT

• 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.

  PMID: 22811565 RESULT

• 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.

  PMID: 21874552 RESULT

• 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.

  PMID: 21058606 RESULT

• 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.

  PMID: 8148862 RESULT

• 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.

  PMID: 17293726 RESULT

• 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.

  PMID: 8008411 RESULT

• 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.

  PMID: 17433675 RESULT

• 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.

  PMID: 10960937 RESULT

• 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.

  PMID: 12091180 RESULT

• 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.

  PMID: 1593914 RESULT

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Fatma Ayvat, Msc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Muhammed Kılınç, Assoc Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Sibel Aksu Yıldırım, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 25, 2017
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)