Complex Exercise Program for Stroke Patients

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05616858
Collaborator
(none)
100
1
2
21.5
4.7

Study Details

Study Description

Brief Summary

The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Complex exercise program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, open-label, case-control studyRandomized, open-label, case-control study
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Study on Efficacy and Safety of Complex Exercise Program for the Stroke Patients After Discharge
Actual Study Start Date :
Mar 18, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Group with exercise program

Behavioral: Complex exercise program
Stretching exercise, aerobic exercise, strengthening and balancing exercise

No Intervention: Control group

Group without exercise program

Outcome Measures

Primary Outcome Measures

  1. Peak VO2 [Baseline evaluation]

    Maximal VO2 from cardiopulmonary exercise test

  2. Peak VO2 [Follow-up evaluation after 4 weeks of exercise program]

    Maximal VO2 from cardiopulmonary exercise test

Secondary Outcome Measures

  1. Functional ambulation category (0-5) [Baseline evaluation]

    6-point functional walking test that evaluates ambulation ability

  2. Functional ambulation category (0-5) [Follow-up evaluation after 4 weeks of exercise program]

    6-point functional walking test that evaluates ambulation ability

  3. Berg balance scale (0-56) [Baseline evaluation]

    Objectively determine a patient's ability to safely balance during a series of predetermined tasks

  4. Berg balance scale (0-56) [Follow-up evaluation after 4 weeks of exercise program]

    Objectively determine a patient's ability to safely balance during a series of predetermined tasks

  5. Timed up and go [Baseline evaluation]

    To determine fall risk and measure the progress of balance

  6. Timed up and go [Follow-up evaluation after 4 weeks of exercise program]

    To determine fall risk and measure the progress of balance

  7. Grip strength [Baseline evaluation]

    measure of muscular strength or the maximum force/tension generated by one's forearm muscles

  8. Grip strength [Follow-up evaluation after 4 weeks of exercise program]

    measure of muscular strength or the maximum force/tension generated by one's forearm muscles

  9. 6-minute walk test [Baseline evaluation]

    practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians

  10. 6-minute walk test [Follow-up evaluation after 4 weeks of exercise program]

    practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians

  11. Figure-of-eight walk test [Baseline evaluation]

    Measurement tool that assesses the ability to walk on a curved path

  12. Figure-of-eight walk test [Follow-up evaluation after 4 weeks of exercise program]

    Measurement tool that assesses the ability to walk on a curved path

  13. Sit-and-reach test [Baseline evaluation]

    Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles

  14. Sit-and-reach test [Follow-up evaluation after 4 weeks of exercise program]

    Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles

  15. Chair sit-to-stand test [Baseline evaluation]

    Testing leg strength and endurance in older adults

  16. Chair sit-to-stand test [Follow-up evaluation after 4 weeks of exercise program]

    Testing leg strength and endurance in older adults

  17. Fugl-Meyer assessment (0-226) [Baseline evaluation]

    Stroke-specific, performance-based impairment index

  18. Fugl-Meyer assessment (0-226) [Follow-up evaluation after 4 weeks of exercise program]

    Stroke-specific, performance-based impairment index

  19. Manual function test (0-32) [Baseline evaluation]

    Evaluate unilateral manual performance in hemiparetic patients after stroke

  20. Manual function test (0-32) [Follow-up evaluation after 4 weeks of exercise program]

    Evaluate unilateral manual performance in hemiparetic patients after stroke

  21. Modified Barthel Index (Korean version) (0-100) [Baseline evaluation]

    Measure of physical disability used widely to assess behaviour relating to activities of daily living

  22. Modified Barthel Index (Korean version) (0-100) [Follow-up evaluation after 4 weeks of exercise program]

    Measure of physical disability used widely to assess behaviour relating to activities of daily living

  23. Body composition analysis [Baseline evaluation]

    Percentage of fat, bone, and muscle in the body

  24. Body composition analysis [Follow-up evaluation after 4 weeks of exercise program]

    Percentage of fat, bone, and muscle in the body

  25. Korean Mini-Mental Status Examination (K-MMSE) (0-30) [Baseline evaluation]

    Screening of dementia and to investigate the possible changes of optimal cutoff scores

  26. Korean Mini-Mental Status Examination (K-MMSE) (0-30) [Follow-up evaluation after 4 weeks of exercise program]

    Screening of dementia and to investigate the possible changes of optimal cutoff scores

  27. Euro-Quality of Life-5 Dimension (EQ-5D) [Baseline evaluation]

    A brief and simple instrument measuring health related quality of life

  28. Euro-Quality of Life-5 Dimension (EQ-5D) [Follow-up evaluation after 4 weeks of exercise program]

    A brief and simple instrument measuring health related quality of life

  29. Getriatic depression scale (0-15) [Baseline evaluation]

    Assessment of depression in the elderly

  30. Getriatic depression scale (0-15) [Follow-up evaluation after 4 weeks of exercise program]

    Assessment of depression in the elderly

  31. International Physical Activity Questionnaire [Baseline evaluation]

    27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old

  32. International Physical Activity Questionnaire [Follow-up evaluation after 4 weeks of exercise program]

    27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital

  • Independent ambulator (FAC over 4)

  • Independent daily activities (Modified Rankin Scale less than 2)

  • No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)

  • Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3

Exclusion Criteria:
  • MMSE less than 18

  • BBS less than 41

  • Severe aphagia who cannot communicate

  • Severe cardiovascular conditions inhibiting exercise programs

  • Musculoskeletal problems inhibiting exercise programs

  • Other medical conditions considered by physiatrists

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Yangsan Hospital Yangsan Gyeongnam Korea, Republic of 50612

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sung-Hwa Ko, Associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT05616858
Other Study ID Numbers:
  • SHKo
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2022