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Protein Supplementation for Chronic Stroke Treatment

Primary Purpose

Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dietary supplementation
Exercise training
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRO group

CHO group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2018
Last Updated
June 7, 2023
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03637270
Brief Title
Protein Supplementation for Chronic Stroke Treatment
Official Title
Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO group
Arm Type
Experimental
Arm Description
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.
Arm Title
CHO group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplementation
Intervention Description
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
Other
Intervention Name(s)
Exercise training
Intervention Description
Including aerobic cycling training and progressive resisted exercise
Primary Outcome Measure Information:
Title
Cardiopulmonary capacity
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Total body lean and fat mass
Description
measured by dual energy X-ray absorptiometry
Time Frame
20 weeks
Title
Timed up and go (TUG)
Description
measures the mixed capacity of balance and walking
Time Frame
20 weeks
Title
Burg Balance Test
Description
measures the balance
Time Frame
20 weeks
Title
CardioPulmonary Exercise Test
Description
measures cardiopulmonary fitness
Time Frame
20 weeks
Title
6 minutes walk test
Description
measures the walking endurance
Time Frame
20 weeks
Title
Physical performance (short physical performance battery)
Description
measured by clinical evaluation
Time Frame
20 weeks
Title
Physical performance (modified physical performance test)
Description
measured by clinical evaluation
Time Frame
20 weeks
Title
Maximal isometric voluntary contraction
Description
measured by clinical evaluation
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin, MD, MS
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of rehabilitation, Shuang-Ho Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Department of rehabilitation, Taipei Tzu-Chi Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Department of rehabilitation, WanFang Hospital
City
Taipei City
Country
Taiwan
Facility Name
Department of rehabilitation, Taipei Medical University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Protein Supplementation for Chronic Stroke Treatment

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