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Protein Supplementation for Chronic Stroke Treatment

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ClinicalTrials.gov Identifier: NCT03637270
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Yen-Nung Lin, Taipei Medical University WanFang Hospital

Brief Summary:
Stroke patients usually have difficulties with moving and are venerable to secondary problems such as sarcopenia and strength loss. These problems may accelerate the disability process during aging. It is well known that exercise helps to maintain or promote human fitness. This study is conducted to explore the beneficial effects of exercise and protein supplement on fitness and body composition among patients with chronic stroke.

Condition or disease Intervention/treatment Phase
Chronic Stroke Dietary Supplement: Dietary supplementation Other: Exercise training Not Applicable

Detailed Description:

This is a multicenter randomized control trial. Participants will be recruited from 4 teaching hospitals in Taipei. Participants are randomly assigned to 2 groups:

  1. protein supplementation + exercise (PRO group);
  2. carbohydrate supplementation + exercise (CHO group);

The 1-hour exercise intervention includes aerobic cycling exercise followed by progressive resisted exercise with TheraBand. PRO group receives PS immediately before and after the exercise while the CHO group receive sham product (the same calories with no protein). The Interventions are arranged 3 sessions a week for 10 weeks. The outcome measurements are performed at 0-week, 10-week, and 20-week.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : December 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRO group
Participants in PRO group receive dietary supplementation with protein-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions.
Dietary Supplement: Dietary supplementation
Before and after each exercise session, the research assistant will give subjects protein supplement or carbohydrate supplement according to the treatment assignment and ask them to drink it down right away.

Other: Exercise training
Including aerobic cycling training and progressive resisted exercise

Active Comparator: CHO group
Participants in CHO group receive dietary supplementation with carbohydrate-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions.
Dietary Supplement: Dietary supplementation
Before and after each exercise session, the research assistant will give subjects protein supplement or carbohydrate supplement according to the treatment assignment and ask them to drink it down right away.

Other: Exercise training
Including aerobic cycling training and progressive resisted exercise




Primary Outcome Measures :
  1. Physical performance [ Time Frame: 20 weeks ]
    measured by clinical evaluation


Secondary Outcome Measures :
  1. Total body lean and fat mass [ Time Frame: 20 weeks ]
    measured by dual energy X-ray absorptiometry

  2. Timed up and go (TUG) [ Time Frame: 20 weeks ]
    measures the mixed capacity of balance and walking

  3. Burg Balance Test [ Time Frame: 20 weeks ]
    measures the balance

  4. CardioPulmonary Exercise Test [ Time Frame: 20 weeks ]
    measures cardiopulmonary fitness

  5. 6 minutes walk test [ Time Frame: 20 weeks ]
    measures the walking endurance

  6. Stroke Specific Quality of Life Scale(SS-QOL) [ Time Frame: 20 weeks ]
    measures the health-related quality of life specific to patients with stroke



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic stroke>6months
  2. Age : 20-75 y
  3. Able to walk independently over 10 mins (with or without orthosis)
  4. Able to use stationary bike

Exclusion Criteria:

  1. Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
  2. Not able to exercise due to severe cardiopulmonary dysfunction
  3. Malnutrition (MNA<11)
  4. Severe obesity (BMI>35)
  5. Renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637270


Contacts
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Contact: Yen-Nung Lin, MD, MS 0970746879 semitune@gmail.com

Locations
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Taiwan
Department of rehabilitation, Shuang-Ho Hospital Recruiting
New Taipei City, Taiwan
Contact: Shih-Wei Huang, MD         
Department of rehabilitation, Taipei Tzu-Chi Hospital Recruiting
New Taipei City, Taiwan
Contact: Chien-Ting Liu, MD         
Department of rehabilitation, WanFang Hospital Recruiting
Taipei City, Taiwan
Contact: Yen-Nung Lin, MD, MS    0970746879    semitune@gmail.com   
Department of rehabilitation, Taipei Medical University Hospital Recruiting
Taipei, Taiwan
Contact: Chien-Hung Lai, MD, PhD         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Principal Investigator: Yen-Nung Lin, MD, MS Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity

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Responsible Party: Yen-Nung Lin, Director of Department of Rehabilitation, WanFang Hospital, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03637270     History of Changes
Other Study ID Numbers: 107-2320-B-038 -016
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases