Chronic StrokeNCT03637270
Protein Supplementation for Chronic Stroke Treatment
A study testing Dietary supplementation and Exercise training in people with Chronic Stroke, run by Taipei Medical University WanFang Hospital at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Dietary supplementation and Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 4 sitesTaiwan
- Study dates
- 19 Dec 2018to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 10 mins (with or without orthosis)
- Able to use stationary bike
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Department of rehabilitation, Shuang-Ho Hospital
New Taipei City
Department of rehabilitation, Taipei Tzu-Chi Hospital
New Taipei City
Department of rehabilitation, Taipei Medical University Hospital
Taipei
Department of rehabilitation, WanFang Hospital
Taipei
About this study
Official title: Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
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.
Read the 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:
- 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.
- Conditions
- Chronic Stroke
- Being tested
- Dietary supplementation, Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementationDietary 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 trainingOther
Including aerobic cycling training and progressive resisted exercise
| Study group | Role | What they receive |
|---|---|---|
| PRO group | Experimental | 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. Receives: Dietary Supplement: Dietary supplementation; Other: Exercise training |
| CHO group | Active comparator | 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. Receives: Dietary Supplement: Dietary supplementation; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary capacity
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.
Measured: 10 weeks
Secondary outcomes (8)
Total body lean and fat mass
measured by dual energy X-ray absorptiometry
Measured: 20 weeks
Timed up and go (TUG)
measures the mixed capacity of balance and walking
Measured: 20 weeks
Burg Balance Test
measures the balance
Measured: 20 weeks
CardioPulmonary Exercise Test
measures cardiopulmonary fitness
Measured: 20 weeks
6 minutes walk test
measures the walking endurance
Measured: 20 weeks
Physical performance (short physical performance battery)
measured by clinical evaluation
Measured: 20 weeks
Physical performance (modified physical performance test)
measured by clinical evaluation
Measured: 20 weeks
Maximal isometric voluntary contraction
measured by clinical evaluation
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start19 Dec 2018
- Primary completion1 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
- Investigators
- Yen-Nung Lin, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637270
- Sponsor's protocol ID
- 107-2320-B-038 -016
- Status last verified
- Jun 2023
- First submitted
- 15 Aug 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin YN, Viswanathan A, Ogawa EF, Knuiman P, Chang CH, Chan WP, Huang SW, Schneider JC, Bean JF, Yeh TS. Effect of protein supplementation on cardiorespiratory fitness with aerobic training in chronic stroke: A multicenter randomized controlled trial. Int J Stroke. 2026 Jun;21(5):613-624. doi: 10.1177/17474930251403727. Epub 2025 Nov 20.
PubMed 41263381Hoh BL, Martin RH, Yeatts SD, Turan TN, Boyette RM, McLaren S, Butler L, Peters KR, Smith J, Cavallari LH, Wabnitz AM, Sabagha N, Unger C, Frasure JS, Broderick JP, Chimowitz MI. Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial. Int J Stroke. 2025 Jun;20(5):623-628. doi: 10.1177/17474930241313301. Epub 2025 Jan 25.
PubMed 39862061
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03637270
- Acronym / sponsor ID
- 107-2320-B-038 -016
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO group | Experimental | Dietary Supplement: Dietary supplementation, Other: Exercise trainingParticipants in PRO group receive dietary supplementation with protein-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions. |
| CHO group | Active comparator | Dietary Supplement: Dietary supplementation, Other: Exercise trainingParticipants in CHO group receive dietary supplementation with carbohydrate-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 10 mins (with or without orthosis)
- Able to use stationary bike
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementationBefore 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. | Dietary supplement | CHO group, PRO group |
| Exercise trainingIncluding aerobic cycling training and progressive resisted exercise | Other | CHO group, PRO group |
Primary outcome
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.
8 secondary outcomes
Total body lean and fat mass
Time frame: 20 weeks
Timed up and go (TUG)
Time frame: 20 weeks
Burg Balance Test
Time frame: 20 weeks
CardioPulmonary Exercise Test
Time frame: 20 weeks
6 minutes walk test
Time frame: 20 weeks
Physical performance (short physical performance battery)
Time frame: 20 weeks
Physical performance (modified physical performance test)
Time frame: 20 weeks
Maximal isometric voluntary contraction
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 41263381Lin YN, Viswanathan A, Ogawa EF, Knuiman P, Chang CH, Chan WP, Huang SW, Schneider JC, Bean JF, Yeh TS. Effect of protein supplementation on cardiorespiratory fitness with aerobic training in chronic stroke: A multicenter randomized controlled trial. Int J Stroke. 2026 Jun;21(5):613-624. doi: 10.1177/17474930251403727. Epub 2025 Nov 20.
- Derived from this study: PubMed 39862061Hoh BL, Martin RH, Yeatts SD, Turan TN, Boyette RM, McLaren S, Butler L, Peters KR, Smith J, Cavallari LH, Wabnitz AM, Sabagha N, Unger C, Frasure JS, Broderick JP, Chimowitz MI. Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial. Int J Stroke. 2025 Jun;20(5):623-628. doi: 10.1177/17474930241313301. Epub 2025 Jan 25.
- Individual participant dataSharing planned: No
Related trials for Chronic Stroke
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Nung Lin, MD, MS principal investigator
Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation and Exercise training in people with Chronic Stroke, run by Taipei Medical University WanFang Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary capacity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.