scholarly journals Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS

2018 ◽  
Vol 71 ◽  
pp. 154-161 ◽  
Author(s):  
Robert W. Motl ◽  
Brian M. Sandroff ◽  
Brooks C. Wingo ◽  
Justin McCroskey ◽  
Lara A. Pilutti ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Phase Iii ◽  
Randomized Controlled

scholarly journals Randomized controlled trial of an e-learning designed behavioral intervention for increasing physical activity behavior in multiple sclerosis

2017 ◽  
Vol 3 (4) ◽  
pp. 205521731773488 ◽  
Author(s):  
Robert W Motl ◽  
Elizabeth A Hubbard ◽  
Rachel E Bollaert ◽  
Brynn C Adamson ◽  
Dominique Kinnett-Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Learning Approaches ◽  
Positive Effects ◽  
Randomized Controlled ◽  
E Learning

Background Internet-delivered, behavioral interventions represent a cost-effective, broadly disseminable approach for teaching persons with multiple sclerosis (MS) the theory-based skills, techniques, and strategies for changing physical activity. Objectives This pilot, randomized controlled trial examined the efficacy of a newly developed Internet website based on e-learning approaches that delivered a theory-based behavior intervention for increasing physical activity and improving symptoms, walking impairment, and neurological disability. Methods Participants with MS ( N = 47) were randomly assigned into behavioral intervention ( n = 23) or waitlist control ( n = 24) conditions delivered over a six-month period. Outcomes were administered before and after the six-month period using blinded assessors, and data were analyzed using analysis of covariance in SPSS. Results There was a significant, positive intervention effect on self-reported physical activity ( P = 0.05, [Formula: see text] = 0.10), and non-significant improvement in objectively measured physical activity ( P = 0.24, [Formula: see text] = 0.04). There were significant, positive effects of the intervention on overall ( P = 0.018, [Formula: see text] = 0.13) and physical impact of fatigue ( P = 0.003, [Formula: see text] = 0.20), self-reported walking impairment ( P = 0.047, [Formula: see text] = 0.10), and disability status ( P = 0.033, [Formula: see text] = 0.11). There were non-significant improvements in fatigue severity ( P = 0.10, [Formula: see text] = 0.06), depression ( P = 0.10, [Formula: see text] = 0.07) and anxiety ( P = 0.06, [Formula: see text] = 0.09) symptoms, and self-reported disability ( P = 0.10, [Formula: see text] = 0.07). Conclusions We provide evidence for the efficacy of an Internet-based behavioral intervention with content delivered through interactive video courses grounded in e-learning principles for increasing physical activity and possibly improving secondary outcomes of fatigue, depression, anxiety, and walking impairment/disability in persons with MS.

Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis

2013 ◽  
Vol 20 (5) ◽  
pp. 594-601 ◽  
Author(s):  
LA Pilutti ◽  
D Dlugonski ◽  
BM Sandroff ◽  
R Klaren ◽  
RW Motl
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Behavioral Intervention ◽  
Behavioral Interventions ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Related Quality ◽  
Lifestyle Physical Activity

Background: Exercise training is beneficial, but most persons with multiple sclerosis (MS) are sedentary and physically inactive. This has prompted a new focus on the promotion of lifestyle physical activity in MS. We previously designed, tested, and refined a behavioral intervention delivered through the Internet that successfully increased lifestyle physical activity in MS, but have not evaluated the effects on secondary symptomatic and health-related quality of life (HRQOL) outcomes. Objective: We conducted a 6-month randomized controlled trial (RCT) that examined the efficacy of an Internet-delivered, behavioral intervention for improving outcomes of fatigue, depression, anxiety, pain, sleep quality, and HRQOL in 82 ambulatory persons with MS. The secondary aim was to replicate previous results regarding change in free-living physical activity. Results: There was a significant and positive effect of the intervention on fatigue severity ( p=.001, ηρ2=.15) and its physical impact ( p=.008, ηρ2=.09), depression ( p=.006, ηρ2=.10), and anxiety ( p=.006, ηρ2=.10). There were non-significant improvements in pain ( p=.08, ηρ2=.04), sleep quality ( p=.06, ηρ2=.05), and physical HRQOL ( p=.06, ηρ2=.05). We replicated our previous results by demonstrating an increase in self-reported physical activity ( p=.001, ηρ2=.13). Conclusions: Our results support behavioral interventions targeting lifestyle physical activity as an alternative approach for managing symptoms in MS.

A phase III study of the impact of a physical activity program on disease-free survival in patients with high-risk stage II or stage III colon cancer: A randomized controlled trial (NCIC CTG CO.21).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS3647-TPS3647
Author(s):  
Christopher M. Booth ◽  
Kerry S. Courneya ◽  
Janette L. Vardy ◽  
Derek J. Jonker ◽  
Sharlene Gill ◽  
...  
Keyword(s):  
Physical Activity ◽  
Colon Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
Face To Face ◽  
Randomized Controlled ◽  
Disease Free

TPS3647 Background: Observational data indicate that physical activity (PA) is strongly associated with colon-cancer specific survival. NCIC CTG CO.21 (CHALLENGE) is designed to determine the effects of a structured PA intervention on disease-control outcomes for survivors of high-risk stage II or III colon cancer who have completed adjuvant chemotherapy within the previous 2-6 months. Methods: Phase III randomized controlled trial. Target sample size of 962 patients is powered to detect a Hazard Ratio of 0.75 for disease-free survival (DFS). Trial participants will be stratified by centre, disease stage, body mass index, and performance status, and will be randomly assigned to a structured, individualized PA intervention or to general health education materials. The PA intervention will consist of a behavioural support program and supervised PA sessions delivered over a 3-year period, beginning with regular face-to-face sessions and tapering to less frequent face-to-face or telephone sessions. The goal of the PA program is to increase weekly PA by 10 MET hours/week. The PA program is delivered by physical activity consultants trained in exercise physiology and behavior change. Outcomes: The primary endpoint is DFS. Important secondary endpoints include multiple patient-reported outcomes (including those that address fatigue), objective physical functioning, biologic correlative markers (including assessment of the insulin pathway), and an economic analysis. Current Enrollment: The study is open at 19 centers in Canada and 20 centers in Australia. Accrual as of February 4, 2013 includes 212 registered and 184 randomized patients. Summary: Cancer survivors and cancer care professionals are interested in the potential role of PA to improve multiple disease-related outcomes, but a randomized controlled trial is needed to provide compelling evidence to justify changes in health care policies and practice. Clinical trial information: NCT00819208.

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