Physical Activity Together for MS (PAT-MS): Pilot Study of a Dyadic Rehabilitation Intervention for People with Moderate-to-Severe Multiple Sclerosis Disability and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Self-Reported Physical Activity - Primary Efficacy Outcome
研究概览
简要总结
Both people with multiple sclerosis (MS) and their family caregivers experience the impact of this neurodegenerative disease on their health and well-being. The person living with MS and their support partner need to work together as a team to find ways to manage the disease. A physical activity (PA) program that uses a 'dyadic approach' is one possible way of managing the impact of MS. Dyadic programs are unique because they target both people with the disease and their caregivers together to increase their PA levels. This pilot study will deliver a 12-week program using group teleconference and one-on-one support phone calls to teach participants simple methods to change PA patterns in daily life. For example, they will learn how to set personal goals to increase PA and reduce sitting time.
详细描述
The study is an assessor-blinded pilot randomized controlled trial (RCT) for examining the feasibility and preliminary efficacy of a dyadic PA intervention approach for persons with MS (PwMS) affected by moderate-to-severe disability and their family caregivers (CGs). Dyads who meet the eligibility requirements will undergo the informed consent process and baseline assessment.
Dyads will then be randomized to either an immediate intervention condition or a delayed control condition. Participants in the immediate intervention group will receive six group teleconference sessions, approximately 60 minutes each, every other week for 12 weeks. These sessions will be interspersed with one-on-one support calls in the weeks that group sessions do not occur. Participants will be provided with a manual for their individual use during the intervention. The intervention content will introduce participants to the concepts of shared appraisal and dyadic coping. The benefits of shared participation in PA as a coping strategy to optimize well-being at both the individual and dyadic level will be reinforced and illustrated. All participants will be taught techniques for monitoring PA behaviour, setting personalized goals to increase PA and reduce sedentary time, and strategies for overcoming challenges to PA participation. The one-to-one support calls will serve to reinforce the information provided during the group sessions, monitor safety, and troubleshoot any issues with the intervention content. All participants will undergo the assessment protocol again at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be collected objectively by researchers who are blinded to treatment allocation. Researchers who are involved with delivery of the intervention will be aware of treatment allocation, but will not be involved with data collection, entry or analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For persons with MS:
- •Physician-confirmed MS diagnosis and stable course of disease modifying therapies over the past 6 months
- •Expanded Disability Status Scale (EDSS) score between 6.0 (intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting) and 6.5 (constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting), based on a Neurostatus-certified assessor examination.
- •Relapse-free in the past 30 days
- •Support Partner (i.e., relative or close friend) who provides greater than or equal to 1.0 hours per day of unpaid care
- •Additional inclusion criteria for both persons with MS and caregivers:
- •Greater than or equal to 18 years of age
- •Currently inactive (i.e., purposeful exercise less than or equal to 2 days/week for 30 minutes)
- •Asymptomatic (i.e. no major signs or symptoms of acute or uncontrolled cardiovascular, metabolic, or renal disease) based on the Get Active Questionnaire
- •Ability to communicate in English
排除标准
- •for both persons with MS and caregivers:
- •diagnosis of other neurological condition(s)
研究组 & 干预措施
Immediate Intervention
PwMS-CG dyads will receive six group telerehabilitation sessions (~60 min each) every other week for a period of 12 weeks. This will be interspersed with brief one-on-one support telephone calls in the weeks that group sessions do not occur. All participants will be taught techniques for monitoring PA behaviour, setting personalized goals to increase PA and reduce sedentary time, and strategies for overcoming challenges to PA participation. Make-up sessions will be offered to those who miss group sessions. The one-on-one support telephone calls will serve to reinforce the information provided during the group sessions, monitor safety and troubleshoot any issues with intervention content.
干预措施: Physical Activity Together for PwMS and their CGs (PAT-MS) (Behavioral)
Delayed Control
The delayed control group will not receive the intervention during the study period. Participants assigned to the control group will be offered the intervention once the study is completed.
结局指标
主要结局
Change in Self-Reported Physical Activity - Primary Efficacy Outcome
时间窗: Change in Self-reported PA (total PA minutes) between T1 (Baseline) and T2 (12 Weeks)
Change in Self-reported physical activity (PA) level of PwMS and CGs will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The GLTEQ has been demonstrated to be a reliable and valid primary outcome for measuring change in PA in response to a behavioural intervention.
Feasibility: Monetary cost of research
时间窗: Recorded from study initiation to completion, approximately 2 years
We will establish and record all monetary costs for the study.
Feasibility: Staff time
时间窗: Recorded weekly through study completion at 12 weeks
We will document all preparation, call time, attempted call time and report-taking time for each participant during the intervention.
Feasibility: Data collection at T1
时间窗: Will be assessed at T1 (Baseline)
We will check for data completeness, and record time to collect, enter and check data in a database
Feasibility: Research ethics procedures
时间窗: Recorded from study initiation to completion, approximately 2 years
We will document communications between the research ethics board and staff, and time from submission of research ethics application to approval.
Feasibility: Data collection at T2
时间窗: Will be assessed at T2 (12 Weeks)
We will check for data completeness, and record time to collect, enter and check data in a database
Safety of the PAT-MS intervention
时间窗: Assessed weekly through study completion at 12 weeks
Safety will be recorded via reporting of adverse events (AEs) during testing sessions and one-on-one support calls. AEs will be defined as any unfavorable change in health that occurs in both PwMS and CGs during the trial period, e.g. injuries, relapses, falls and symptomatic changes. Each AE will be rated based on severity, expectedness, and potential relation to study participation using the Common Terminology for Adverse Events (CTCAE) classification scheme. AEs will be reported as the overall rate, severity, and characteristics of the events.
Feasibility: Participant recruitment rate
时间窗: Recorded through the 6-month recruitment period
We will use phone call and electronic mail recruitment and record all contact with potential participants and refusal reasons.
Feasibility: Participant compliance rate
时间窗: Recorded weekly through study completion at 12 weeks
Will be assessed by recording the number of practice activities, group teleconference sessions, and one-on-one phone calls completed by participants.
Feasibility: Participant attrition rate
时间窗: Will be assessed at T2 (12 Weeks)
Will be assessed as the percentage of the sample who drop out of the study.
次要结局
- Change in Accelerometer-measured Physical Activity - steps/day(Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks).)
- Change in Accelerometer-measured Physical Activity - minutes of PA(Change in accelerometer-measured minutes of PA between T1 (Baseline) and T2 (12 Weeks).)
- Change in Agility(Change in Agility between T1 (Baseline) and T2 (12 Weeks).)
- Change in Quality of Life in PwMS(Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks).)
- Change in Walking Endurance(Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks))
- Change in Walking Speed(Change in walking speed between T1 (Baseline) and T2 (12 Weeks).)
- Change in Physical Functional Limitations and Disability(Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks).)
- Change in Coping(Change in Coping in CGs between T1 (Baseline) and T2 (12 Weeks).)
- Change in MS Self-Efficacy(Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks).)
- Change in Dyadic Relationship Quality(Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks))
- Change in Perceptions of Social Support(Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks).)
- Change in Resilience(Change in Resilience between T1 (Baseline) and T2 (12 Weeks).)
- Change in Quality of Life in Caregivers(Change in Quality of life in CGs between T1 (Baseline) and T2 (12 Weeks).)
研究者
Lara Pilutti
Associate Professor
University of Ottawa