Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT01572207

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Immediate exercise
  • Delayed exercise

Results by group

Changes From Baseline in Physical Activity Behavior

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).

GroupValueIntervalNumber analysed
Immediate Exercise14.36 scores on a scale0–3614
Delayed Exercise16.22 scores on a scale0–6416
Immediate Exercise33.07 scores on a scale0–8514
Delayed Exercise21.00 scores on a scale0–4516
Immediate Exercise26 scores on a scale0–5814
Delayed Exercise23.06 scores on a scale3–4316

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Immediate Exercise140 (0.0%)
Delayed Exercise160 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Changes From Baseline in Physical Activity Behavior

    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).

    Physical function

Other measures (2)

  • Changes From Baseline in Physical Fitness

    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).

    Walking and mobilityPhysical function
  • Changes From Baseline in Quality of Life

    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).

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this research study is to evaluate whether tailored print material can promote physical activity and exercise, and subsequently improve quality of life and fitness levels among people with multiple sclerosis (MS). Research suggests that routine physical activity is beneficial in people with mild to moderate MS. However, people with MS may face many barriers for engaging in regular physical activity. Prescribing a home exercise program and receiving tailored motivational print material may help people engage in physical activity. Thus, the investigators hope to figure out whether tailored print material can be used as strategy to promote physical activity and improve physical function in people with MS.

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History

    1. Started

      Jul 2011

    2. Main results due

      Jul 2012

    3. Finished

      Jul 2012

    4. Results posted

      Jan 2015

    Assembled by software from public sources.