Beta
Trial Radar KI
enums.trial_summary.trial_summary_welcome
Eine Studie entspricht den Filterkriterien
Kartenansicht
Zurück zur Suche

Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

Aktiv, nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05285748 untersucht Prävention im Zusammenhang mit Körperliche Inaktivität. Diese interventionsstudie der Phase 2 hat den Status aktiv, nicht rekrutierend und startete am 15. März 2022. Es ist geplant, 258 Teilnehmer aufzunehmen. Durchgeführt von Brown-Universität wird der Abschluss für 1. Mai 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Mai 2025 aktualisiert.
Kurzbeschreibung
We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.
Offizieller Titel

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

Erkrankungen
Körperliche Inaktivität
Weitere Studien-IDs
NCT-Nummer
NCT05285748
Studienbeginn (tatsächlich)
2022-03-15
Zuletzt aktualisiert
2025-05-29
Studienende (vorauss.)
2026-05
Geplante Rekrutierung
258
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Aktiv, nicht rekrutierend
Stichwörter
Physical activity
Exercise
Self-pacing
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellSelf-Paced Intensity Physical Activity
Self-paced Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.
Aktives VergleichspräparatPrescribed Moderate Intensity Physical Activity
Prescribed Moderate Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in total volume of structured PA
Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Measured at baseline, and months 3, 6, 9, and 12.
Minutes per week of PA
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Changes in Body Weight
Assessment of self-reported body weight by study-provided scales
Measured at baseline, and months 3, 6, 9, and 12.
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
50 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • ages 50-64
  • BMI 25-40
  • Sedentary or low-active, defined as participating in < 60 min/week of structured exercise
  • Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

  • Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):

    • Past 3-month overnight hospitalization
    • Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm
    • Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
    • Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
    • Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
    • Past 6-month seizure
    • Past 6-month overnight hospitalization due to respiratory disease
    • Past 6-month lightheadedness, vertigo, dizziness, or fainting
    • Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
    • Takes insulin and/or medication that affects the secretion of insulin
    • Exercise-induced asthma that prevents brisk walking
    • Takes anticonvulsant medication or medication to treat/control seizures
    • Diagnosed with cystic fibrosis
    • Bone or joint problems that make you unable to walk for at least 30 minutes
    • Physician has said not to exercise because of bone or joint problems
    • Physician has said a hip or knee replacement will be needed in the next 12 months
    • Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes

  • Currently taking or planning on taking medications that affect HR, such as beta or calcium channel blockers or digoxin, as HR will be used to determine the moderate intensity range for participants assigned to that condition

  • Past 12-month overnight psychiatric hospitalization

  • Currently pregnant or planning to become pregnant in the next year

  • Currently participating in any exercise or weight-loss research studies

  • Household member is participating in this study

  • Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box

  • Unable to receive materials in the mail at residential mailing address

  • Does not plan to live in Rhode Island for the next 12 months

  • Unable to speak, read, and/or write fluently in English

  • Smokers will be eligible, but smoking status will be included as a covariate in analyses

Brown University logoBrown-Universität116 aktive klinische Studien zum Erkunden
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
Verantwortliche Partei
David M. Williams, Hauptprüfer, Professor, Brown University
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Rhode Island

Brown University, Providence, Rhode Island, 02912, United States