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

29. juli 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Muscle Disease Group
Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days
Enhed: 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).
Aktiv komparator: Healthy Individuals Group
Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days
Enhed: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Energy expenditure on SenseWear Activity Monitor
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
International Physical Activity Scale (IPAQ)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hacettepe University

Efterforskere

  • Ledende efterforsker: Fatma Ayvat, Msc, Hacettepe University
  • Ledende efterforsker: Muhammed Kılınç, Assoc Prof, Hacettepe University
  • Studieleder: Sibel Aksu Yıldırım, Prof, Hacettepe University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2016

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

15. januar 2017

Først indsendt, der opfyldte QC-kriterier

21. januar 2017

Først opslået (Skøn)

25. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GO 14/617

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med SenseWear activity monitor

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