- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01572207
Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- The Cleveland Clinic
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- A physician-confirmed diagnosis of relapsing-remitting MS
Exclusion Criteria:
- Exercise more than 150 minutes per week
- Pregnant
- Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
- Four or more falls in the past 6 months
- Be able to walk 25 feet with or without a cane
- Severe cognitive deficits
- Unable to read at a 6th grade level
- A condition besides MS that had lead to hospitalization in the past year
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Immediate Exercise
Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting.
During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity.
In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
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Subjects in the immediate exercise group will be prescribed a home exercise program during the first meeting and will begin the 12 week training period immediately following the first meeting.
Andere Namen:
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Experimental: Delayed exercise
Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting.
During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
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Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes From Baseline in Physical Activity Behavior
Zeitfenster: Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean. With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity. |
Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes From Baseline in Physical Fitness
Zeitfenster: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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The physical assessment will include measuring the 6-minute walk test.
The units reported are in meters for distance traveled by each participant during the six minutes.
For this scale, the higher number is the better score as it is a direct measure of distance traveled.
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Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Changes From Baseline in Quality of Life
Zeitfenster: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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The Multiple Sclerosis Impact Scale will be administered.
The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome).
Therefore, the lower the number, the better the outcome.
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Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Matthew Plow, PhD, Case Western Reserve University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 10-531
- 1R03HD060073-01A1 (US NIH Stipendium/Vertrag)
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