NCT03637270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

4.3 years

First QC Date

August 15, 2018

Last Update Submit

June 7, 2023

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Total body lean and fat mass

    20 weeks

  • Timed up and go (TUG)

    20 weeks

  • Burg Balance Test

    20 weeks

  • CardioPulmonary Exercise Test

    20 weeks

  • 6 minutes walk test

    20 weeks

  • +3 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: Dietary supplementationOther: 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.

Dietary Supplement: Dietary supplementationOther: Exercise training

Interventions

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.

CHO groupPRO group
Exercise trainingOTHER

Including aerobic cycling training and progressive resisted exercise

CHO groupPRO group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of rehabilitation, Shuang-Ho Hospital

New Taipei City, Taiwan

Location

Department of rehabilitation, Taipei Tzu-Chi Hospital

New Taipei City, Taiwan

Location

Department of rehabilitation, Taipei Medical University Hospital

Taipei, Taiwan

Location

Department of rehabilitation, WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Dietary SupplementsExercise

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yen-Nung Lin, MD, MS

    Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Rehabilitation, WanFang Hospital

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

December 19, 2018

Primary Completion

April 1, 2023

Study Completion

April 3, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(4)