Protein Supplementation for Chronic Stroke Treatment

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Dietary supplement: Dietary supplementation; Other: Exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Department of rehabilitation, Shuang-Ho Hospital
  • New Taipei City, Taiwan
    • Department of rehabilitation, Taipei Tzu-Chi Hospital
  • Taipei, Taiwan
    • Department of rehabilitation, Taipei Medical University Hospital
  • Taipei City, Taiwan
    • Department of rehabilitation, WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body lean and fat mass	measured by dual energy X-ray absorptiometry	20 weeks
Timed up and go (TUG)	measures the mixed capacity of balance and walking	20 weeks
Burg Balance Test	measures the balance	20 weeks
CardioPulmonary Exercise Test	measures cardiopulmonary fitness	20 weeks
6 minutes walk test	measures the walking endurance	20 weeks
Physical performance (short physical performance battery)	measured by clinical evaluation	20 weeks
Physical performance (modified physical performance test)	measured by clinical evaluation	20 weeks
Maximal isometric voluntary contraction	measured by clinical evaluation	20 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yen-Nung Lin, MD, MS, Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 107-2320-B-038 -016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No