Protein Supplementation for Chronic Stroke Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2023-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of BCAA-rich Protein Supplements for Chronic Stroke Patients

NCT03244527

Stroke

COMPLETED NA

The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

NCT01810263

Stroke Malnutrition

TERMINATED PHASE2/PHASE3

Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

NCT06874140

Acute Ischemic Stroke

COMPLETED PHASE1

Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

NCT00950521

Stroke Middle Cerebral Artery Infarction

COMPLETED PHASE2

Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke

NCT05559307

Ischemic Stroke, Acute

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dietary supplementation

Intervention Type 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

Intervention Type OTHER

Including aerobic cycling training and progressive resisted exercise

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.

Group Type ACTIVE_COMPARATOR

Dietary supplementation

Intervention Type 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

Intervention Type OTHER

Including aerobic cycling training and progressive resisted exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Exercise training

Including aerobic cycling training and progressive resisted exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
6. 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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No