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Physical Activity to Improve Physical Function in a Community-Based Health Ministry

8. marts 2021 opdateret af: Brittney Lange-Maia, Rush University Medical Center

Physical Activity to Improve Physical Function in a Community-Based Health Ministry in Chicago's West Side

This study is being conducted to test if a program with physical activity and learning about movement (including goal setting, benefits of physical activity, and how to increase physical activity gradually) helps people to become more active and to move better. The physical activity program involves specific exercises done in a group setting, and the education part will involve learning about different ways to move to make everyday activities easier. The program will last 16 weeks. This program will take place in a large fellowship area of a partner church through an established community-based participatory research partnership in Chicago, IL.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Limitations in physical function (PF) are related to decreased quality of life and are predictive of disability, nursing home admission, increased healthcare costs, and mortality in older adults. Structured physical activity has been shown to prevent mobility disability among those with physical function limitations, though community-based programs are needed, particularly in underserved communities. The purpose of this study is to pilot test a tailored physical activity intervention in churches in Chicago's West Side through an existing community-based participatory research partnership. The investigators previously found high rates of physical function limitations in these communities, and through qualitative research have identified intervention components that may aid in promoting physical activity among community members with physical function limitations. The primary aim is test the intervention in a 16 week, proof-of-concept study in 20 participants who are ambulatory but have PF limitations. The group-based physical activity intervention will take place in a large common area of a church. For feasibility the investigators will be testing the intervention in one church. The intervention will be delivered over 16 weeks, with assessments at baseline and 16 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 40 or older
  2. Not currently participating in another formal exercise program and perform less than 150 minutes per week of exercise
  3. Ambulatory, defined as able to get out of a chair and walk without assistance aside from using a straight cane.
  4. Have any difficulty: Walking ¼ mile, (about 2-3 blocks) OR Walking up 10 steps without resting
  5. Speak English
  6. Safe to begin an exercise program (determined using the Exercise Assessment and Screening for You (EASY) Tool. Physician clearance may be needed based upon EASY Screening recommendations

Exclusion Criteria:

  1. Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
  2. Plans to move out of the geographic area during the study period
  3. Plans to have major surgery within the study period Anticipate having major schedule changes that would interfere with ability to participate in the program.
  4. Inability to get to intervention location on a weekly basis
  5. Unwilling to commit to a weekly, approximately 90 minute program for 16 weeks.
  6. Contraindications to exercise determined using the EASY/healthcare follow-up.
  7. Self-reported

    • Heart disease
    • Uncontrolled diabetes mellitus
    • Pacemaker
    • Stroke within past 12 months
    • Severe chronic lung disease (emphysema or COPD)
    • Recent healing or unhealed fractures in the past 6 months
    • Heart failure
    • Chronic kidney disease

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Physical Activity
16 week physical activity intervention
Participants will meet in a weekly group session to discuss a topic related to physical activity and physical function and participate in group-based physical activity. Participants will also have instructions to participate in physical activity outside of the weekly sessions, incrementally increasing their total physical activity over the intervention period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Function
Tidsramme: 16 weeks
Change in Short Physical Performance Battery score Scale ranges from 0-12 (integers only) with higher scores indicating better function.
16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Activity (Objective)
Tidsramme: 16 weeks
Change in accelerometer measured physical activity (minutes of moderate/vigorous physical activity per day, and number of steps per day). Accelerometer will be worn for 1 full week at the hip but removed for sleep at night). Higher positive values of change indicate larger increases in physical activity.
16 weeks
Physical Activity (Self-Reported)
Tidsramme: 16 weeks
Change in physical activity as assessed by the Champs physical activity. questionnaire. Activity will be expressed as caloric expenditure/week in all exercise-related activities (in calories per week). Higher positive values of change indicate larger increases in physical activity.
16 weeks
Acceptability of intervention:
Tidsramme: 16 weeks
Acceptability questionnaire specific to intervention, attendance (% of sessions attended out of 16 total)
16 weeks

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

16. december 2019

Primær færdiggørelse (Faktiske)

4. september 2020

Studieafslutning (Faktiske)

4. september 2020

Datoer for studieregistrering

Først indsendt

16. december 2019

Først indsendt, der opfyldte QC-kriterier

17. december 2019

Først opslået (Faktiske)

18. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORA18122105

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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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 Physical Activity

Abonner