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Completed

NCT Number: NCT03637270

Protein Supplementation for Chronic Stroke Treatment

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of rehabilitation, Shuang-Ho Hospital, New Taipei City, Taiwan

Loading trial locations.

About this study

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

  • protein supplementation + exercise (PRO group);
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
  • Not able to exercise due to severe cardiopulmonary dysfunction
  • Malnutrition (MNA<11)
  • Severe obesity (BMI>35)
  • Renal insufficiency
  • Unable to tolerate our cardiopulmonary exercise test (CPET) (eg, too short stature to fit the machine, leg spasticity is too strong to peddle the cycling, unable to maintain 50 rpm at the beginning of CPET, indications for early termination of CPET based on the American College of Sport Medicine suggestions)

Treatment and study plan

Dietary supplementation

Dietary Supplement

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.

Exercise training

Other

Including aerobic cycling training and progressive resisted exercise

Primary outcomes

  1. Cardiopulmonary capacity

    Time frame: 10 weeks

    VO2-peak. Oxygen consumption (VO2- peak) were measured during our cardiopulmonary test (with a ramped stationary biking and a gas analyzer). The workload was increased at a ramp rate of 5-10 W/min. A cadence at 50~70 rpm was to be maintained.

Secondary outcomes

  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. Physical performance (short physical performance battery)

    Time frame: 20 weeks

    measured by clinical evaluation

  7. Physical performance (modified physical performance test)

    Time frame: 20 weeks

    measured by clinical evaluation

  8. Maximal isometric voluntary contraction

    Time frame: 20 weeks

    measured by clinical evaluation

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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