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

29. Juli 2020 aktualisiert von: Fatma Ayvat, Hacettepe University

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Truthahn
      • Ankara, Truthahn, 06100
        • Hacettepe University, Faculty of Health Sciences

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Muscle Disease Group
Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days
Gerät: 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).
Aktiver Komparator: Healthy Individuals Group
Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days
Gerät: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Energy expenditure on SenseWear Activity Monitor
Zeitfenster: 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).
5 days
Number of steps on SenseWear Activity Monitor
Zeitfenster: 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.
5 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
International Physical Activity Scale (IPAQ)
Zeitfenster: 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.
10 minutes
Visual Analog Scale
Zeitfenster: 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.
2 minutes
Fatigue Severity Scale
Zeitfenster: 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.
5 minutes
ACTIVLIM questionaire
Zeitfenster: 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.
5 minutes
Medical Outcomes Short-Form Health Survey
Zeitfenster: 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.
10 minutes
Hand Held Dynamometry
Zeitfenster: 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.
20 minutes
Six Minutes Walk Test
Zeitfenster: 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.
10 minutes
Timed Up and Go Test
Zeitfenster: 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.
2 minutes

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hacettepe University

Ermittler

  • Hauptermittler: Fatma Ayvat, Msc, Hacettepe University
  • Hauptermittler: Muhammed Kılınç, Assoc Prof, Hacettepe University
  • Studienleiter: Sibel Aksu Yıldırım, Prof, Hacettepe University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2016

Primärer Abschluss (Tatsächlich)

1. Juni 2017

Studienabschluss (Tatsächlich)

1. Juli 2017

Studienanmeldedaten

Zuerst eingereicht

15. Januar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Januar 2017

Zuerst gepostet (Schätzen)

25. Januar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juli 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2020

Zuletzt verifiziert

1. Juli 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GO 14/617

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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