Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis

Browse trials for

• Multiple Sclerosis 3,524
• Motor Activity 2,646

Keywords

• exercise

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Study arms

• Experimental
  SPIN exercise-training condition

  Behavioral: SPIN exercise-training

• Active comparator
  WELL attention/contact wellness control condition

  Behavioral: Control Condition (WELL)

Interventions

• BehavioralSPIN exercise-training

  Participants complete three days of both modalities each week, with at least one day of rest between resistance sessions. For the first two weeks, all participants begin at 10-minute aerobic sessions and 1 set of 10 repetitions of five resistance exercises. The aerobic goal is to progress to 30-minute sessions (90 minutes/week) using a cycle (arm) ergometer; the resistance goal is 2 sets of 15 repetitions of 10 exercises (\~60 minutes/week). After two weeks, participants select one of three progression tracks (white, blue, or orange) with their coach. The final overall goal is 30 minutes of aerobic exercise plus 10 resistance exercises for two sets of 15 repetitions, three days per week (\~150 minutes/week of MVPA).The total time is 16 weeks.

• BehavioralControl Condition (WELL)

  The WELL attention/contact control mirrors SPIN in coaching schedule and materials but focuses on health behaviors other than physical activity (diet, emotions, stress, sleep, fatigue, and falls). It is based on Social Cognitive Theory (SCT) principles and integrates National Multiple Sclerosis Society (NMSS) wellness resources. WELL includes 12 newsletters (Diet, Sleep, Stress, Balance, Cognition, and Fatigue).

Primary outcomes

1. Change in self reported total minutes per week of moderate-to-vigorous physical activity (MVPA)

   Time frame: Baseline , 16 weeks.

2. Change in strength training, assessed by the Leisure Time Physical Activity Questionnaire for People with Disabilities (LTPAQ-D)

   Participants report the number of days and average minutes per day spent in mild-, moderate-, and vigorous-intensity aerobic activities during the previous 7 days. Weekly minutes are calculated separately for each intensity and summed to obtain total aerobic physical activity, expressed in minutes per week. Higher values indicate greater participation in leisure-time aerobic physical activity

   Time frame: Baseline , 16 weeks

Secondary outcomes

1. Change in device-measured exercise behavior

   Physical activity is measured using an ActiGraph GT3X+ triaxial accelerometer worn on the non-dominant wrist for 7 consecutive days. Acceleration data from the three axes are combined to derive vector magnitude activity counts. Total vector magnitude activity counts are calculated using the study-specified accelerometer data processing and aggregation methods.

   Time frame: Baseline , 16 weeks

2. Change in Upper-limb function as assessed by the Nine-Hole Peg Test

   Upper-limb dexterity is assessed using the Nine-Hole Peg Test (NHPT). Participants are instructed to place nine pegs into a pegboard and remove them as quickly as possible. Performance is measured by the time required to complete the task, recorded in seconds. A decrease in completion time indicates improved manual dexterity.

   Time frame: Baseline , 16 weeks

3. Change in Upper-limb function as assessed by the Grip strength using the hand dynamometer

   Grip strength is assessed using a hand dynamometer. Participants squeeze the dynamometer according to the study protocol, and grip strength is recorded in kilograms s. An increase in grip strength indicates improved grip force.

   Time frame: Baseline , 16 weeks

4. Change in Disability / Activities of Daily Living ( ADL) as assessed by the Barthel Index score

   The Barthel Index will be used to assess changes in participants' independence in activities of daily living (ADLs), including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair climbing. Total scores range from 0 to 100 with higher scores indicating greater independence and lower scores indicating greater dependence.

   Time frame: Baseline , 16 weeks

5. Change in Health-Related Quality of Life as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

   The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a 29-item, patient-reported outcome measure that assesses the physical and psychological impact of multiple sclerosis on health-related quality of life. The scale includes 20 physical-impact items and 9 psychological-impact items. Scores are transformed to a 0-100 scale, with higher scores indicating greater impact of multiple sclerosis and worse health-related quality of life.

   Time frame: Baseline , 16 weeks