- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02100020
Implementing Physical Activity Guidelines for Adults With MS
A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.
This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 4K1
- McMaster University, Physical Activity Centre for Excellence
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Kingston, Ontario, Kanada, K7L 3N6
- Queens University
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Exclusion Criteria:
- current participation in regular physical activity (at least twice-weekly)
- other serious medical condition that might impair ability to participate in strength or aerobic exercise
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Direct Referral to Physical Activity
The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.
|
Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
|
Inget ingripande: Control
The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Adherence to the Physical Activity Guidelines
Tidsram: 3 years
|
Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.
|
3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physical Fitness
Tidsram: At baseline and after the 16 week intervention
|
Peak oxygen uptake, maximum muscle strength, bodyweight
|
At baseline and after the 16 week intervention
|
Perceived Quality of Life
Tidsram: At baseline and after the 16 week intervention
|
Multiple Sclerosis Quality of Life (MSQoL) scale
|
At baseline and after the 16 week intervention
|
Fatigue
Tidsram: At baseline and after the 16 week intervention
|
Multiple Sclerosis Fatigue Impact Scale (MSFIS)
|
At baseline and after the 16 week intervention
|
Mobility
Tidsram: At baseline and after the 16 week intervention
|
25ft walk test
|
At baseline and after the 16 week intervention
|
Blood markers of cardiovascular disease risk
Tidsram: At baseline and after the 16 week intervention
|
blood lipid panel, HbA1c, fasting glucose
|
At baseline and after the 16 week intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Audrey L Hicks, Ph.D., McMaster University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MSProject2001
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