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Physical Activity Intervention for Individuals Newly Diagnosed With MS (ActivNMS)

2026年7月25日 更新者:Robert W Motl、University of Illinois at Chicago

Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing

The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap.

Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group.

Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.

調査の概要

状態

まだ募集していません

詳細な説明

Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercise interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. In this study, the investigators aim to primarily test the effect of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), on the psychological constructs based on the Capability-Opportunity-Motivation-Behavior model in persons newly diagnosed with MS (disease duration ≤ 2 years). Consequently, this could provide more evidence for the understanding of the intervention mechanism on physical activity behavior in people newly diagnosed with MS. Participants will complete a battery of questionnaires remotely over the internet before and immediately after the 16-week program. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The participants could opt in/out of receiving the intervention after the follow-up assessment. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Lexi Huynh, PhD
  • 電話番号:312-996-6615
  • メール:activnms@uic.edu

研究場所

    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • University of Illinois Chicago
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • aged 18 years or older
  • self-reported diagnosis of MS by a neurologist within the past 2 years
  • relapse-free for the past 30 days
  • ability to speak and read English as the primary language
  • internet and e-mail access
  • willingness to complete study protocol
  • ambulatory without an assistive device (PDDS < 3)
  • insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
  • visual ability and literacy to read newsletter with font size 14 points
  • on a stable disease-modifying therapy for 6 months

Exclusion Criteria:

  • pregnant
  • have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:キャンセル待ち管理
実験的:Treatment
COM-B-based Physical Activity Behavior Intervention

Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach:

The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels.

Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity.

The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS.

The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Knowledge and Information Provision Questionnaire (NIP)
時間枠:Baseline and week 16

The Knowledge and Information Provision questionnaire will be administered remotely for self-report assessment of knowledge about physical activity.

3 items; Likert scale 1 - 4 (No - Yes, comprehensively)

Baseline and week 16
Multidimensional Outcome Expectations for Exercise Scale (MOEES)
時間枠:Baseline and week 16

The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity/exercise.

15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree)

Baseline and week 16
Behavioral Intention
時間枠:Baseline and week 16

The behavioral intention will be administered remotely for physical activity behavioral intentions.

5 items; Likert scale 1- 4 (Not true - Completely true)

Baseline and week 16
Exercise Goal Setting Scale (EGS)
時間枠:Baseline and week 16
The EGS will be administered remotely to capture goal-setting skills. It includes 10 items rates on a Likert scale with anchors of 1 (Does not describe) and 5 (Describes completely)
Baseline and week 16
Behavioral Regulation Action Planning (BRAP) Subscale
時間枠:Baseline and week 16
The BRAP will be administered remotely for capturing the action planning construct. 5 items; Likert scale 1 - 4 (Not true - Completely true)
Baseline and week 16
Behavioral Regulation Action Control (BRAC) Subscale
時間枠:Baseline and week 16
The BRAC will be administered remotely for capturing the action control construct. 6 items; Likert scale 1 - 4 (Not true - Completely true)
Baseline and week 16
HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
時間枠:Baseline and week 16
The Self-efficacy subscales will be administered remotely for capturing the self-efficacy levels in physical activity action, recovery, and maintenance. 9 items; Likert scale 1 - 4 (Not true - Exactly true)
Baseline and week 16
Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
時間枠:Baseline and week 16
The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
Baseline and week 16
The PA-Related Social Support Scale (PASS)
時間枠:Baseline and week 16
The PA-Related Social Support Scale will be administered remotely for capturing physical activity social support 7 items; Likert scale 1 - 4 (Almost never - Almost always)
Baseline and week 16
The Physical and Social Environment Barriers - Self-developed questionnaire
時間枠:Baseline and week 16

The Physical and Social Environment Barriers will be administered remotely for capturing barriers in physical and social environment.

9 items; Likert scale 1 - 4 (Is not applicable - Applicable)

Baseline and week 16

二次結果の測定

結果測定
メジャーの説明
時間枠
Physical Activity Behavior
時間枠:Baseline and week 16
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
Baseline and week 16
Physical Activity Behavior
時間枠:Baseline and week 16
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Baseline and week 16
Formative Evaluation
時間枠:Week 16
Self-report survey to assess participant satisfaction and collect feedback from participant.
Week 16

その他の成果指標

結果測定
メジャーの説明
時間枠
Demographic information
時間枠:Baseline
Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
Baseline
Clinical characteristics
時間枠:Baseline and week 16
Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
Baseline and week 16

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Robert Motl, PhD、University of Illinois at Chicago

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2028年10月1日

試験登録日

最初に提出

2026年7月22日

QC基準を満たした最初の提出物

2026年7月25日

最初の投稿 (実際)

2026年7月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月28日

QC基準を満たした最後の更新が送信されました

2026年7月25日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Individual participant data will not be shared. The data will be analyzed after follow-up data collection, and findings will be published on scientific journals

IPD 共有時間枠

Pre-enrollment on ClinicalTrials.gov

IPD 共有アクセス基準

No Criterial for access

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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いいえ

米国FDA規制機器製品の研究

いいえ

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