Idle Time Exercise for Stroke Recovery

Overseen By Kim D Bassindale, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Disqualifiers: Concurrent illness, severe pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 3-12 days

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This project evaluates the feasibility of using custom wearable technology and associated procedures to increase activity of the more-involved upper extremity during the earliest stages of recovery from stroke by increasing the amount of therapeutic exercise during idle-time. The proposed research is relevant to public health because it takes steps to mitigate a significant problem in physical rehabilitation using low-cost technology to motivate and monitor idle-time exercise without adding significantly to clinician workloads. The project aligns with the NICHD / NCMRR Research Plan on Rehabilitation by exploiting a mobile health (mHealth) and sensor-based approach to promote health and wellness through participant-engaged, data-driven, individualized care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Idle Time Exercise for stroke recovery?

The research highlights that stroke patients often spend a lot of time inactive during rehabilitation, suggesting that increasing physical activity could be beneficial. Although not directly about Idle Time Exercise, studies indicate that more activity is linked to better functional abilities, implying that exercises during idle times might help improve recovery. ^{1 2 3 4 5}

Is Idle Time Exercise safe for humans?

Research on exercise after stroke, including light-intensity exercises, suggests it is generally safe and can improve health without causing harm. Studies show that exercise programs, even those involving breaks in sitting time, are safe and beneficial for stroke survivors. ^{2 6 7 8 9}

How does the Idle Time Exercise treatment differ from other stroke recovery treatments?

Idle Time Exercise is unique because it focuses on reducing sedentary behavior by incorporating activity monitoring, scheduling, and problem-solving to encourage engagement in daily activities, unlike traditional therapies that may not specifically target sitting time. ^{1 2 10 11 12}

Eligibility Criteria

This trial is for stroke survivors currently in Froedtert Memorial Hospital's rehab unit, who had a stroke within the last month. Participants must be adults able to consent and follow instructions, with varying degrees of arm impairment as measured by the Fugl-Meyer Motor Assessment.

Inclusion Criteria

I had a stroke on one side of my brain within the last month.

My arm and hand movement is limited.

Ability to give informed consent and follow two-stage instructions

Exclusion Criteria

I can understand and follow basic instructions and can give informed consent.

I do not have any illness or severe pain that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 practice sessions using wearable technology to encourage arm movement post-stroke

3-12 days

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including interviews and device use at home

2 months

1 interview (virtual), 2 days of device use (home)

Treatment Details

Interventions

• Idle Time Exercise

Trial Overview The study tests if wearable technology can help increase use of the more-affected arm during early stroke recovery. It aims to encourage exercise during idle times without increasing clinician workloads, using mobile health approaches for personalized care.

Participant Groups

Group I: Survivors of stroke in early stages of recovery Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Findings from Research

This study will assess the impact of feedback from a Smart watch on daily physical activity levels in stroke rehabilitation patients, with a focus on improving mobility and functional activities over a 3-week period.

Participants will be randomly assigned to receive either regular activity feedback or no feedback while wearing the Smart watch, allowing researchers to evaluate the effectiveness of feedback on enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. Dong, Y., Steins, D., Sun, S., et al.[2022]

Stroke is a major cause of disability, and currently, only 5-10% of stroke patients receive hyperacute revascularization procedures, highlighting the need for timely interventions.

Early prescribed exercise after a stroke can have significant long-term benefits, but there is a lack of guidelines for clinicians on how to safely implement these activities, necessitating a better understanding of the evidence and physiological principles involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. Bahouth, MN., Deluzio, S., Pruski, A., et al.[2023]

Progressive strength and low-intensity aerobic exercise programs lasting 3 to 6 months can significantly improve motor function, strength, balance, and overall fitness in stroke survivors without worsening spasticity.

Increasing access to community-based physical activity programs is crucial for preventing deconditioning and enhancing the quality of life for individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. Engardt, M., Grimby, G.[2017]

A scoping review of 13 studies involving 452 participants found that submaximal aerobic exercise testing protocols for individuals post-stroke can be safely implemented without serious adverse events, addressing concerns about cardiovascular risks.

The most common comorbidities among participants included hypertension (41%), diabetes (31%), and dyslipidemia (27%), indicating that these factors should be considered when designing exercise protocols for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. Legasto-Mulvale, JM., Inness, EL., Thompson, AN., et al.[2023]

A systematic review of 52 studies with 1928 stroke survivors found that interventions involving repetitive practice significantly improve muscle strength, with a standardized mean difference (SMD) of 0.25, indicating a moderate effect.

Improvements in strength from repetitive practice are also associated with enhanced activity levels, particularly in lower limb function (SMD of 0.25) and to a lesser extent in upper limb function (SMD of 0.15).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions involving repetitive practice improve strength after stroke: a systematic review. de Sousa, DG., Harvey, LA., Dorsch, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Accelerometers to Examine Sedentary Time on an Acute Stroke Unit. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Stroke survivor activity during subacute inpatient rehabilitation: how active are patients? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Trajectories and Functional Recovery After Acute Stroke Among Adults in Sweden. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity in hospitalised stroke patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Breaking up sitting time after stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): Protocol for a dose-finding study. [2020]

8. Sweden pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Development and feasibility of a sedentary behavior intervention for stroke: a case series. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Breaking up sitting time after stroke (BUST-Stroke). [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Interventions involving repetitive practice improve strength after stroke: a systematic review. [2022]