NCT02938416

Brief Summary

Our participants will include 40 patients within one month of stroke, 43 patients who received total hip replacement or total knee replacement two to four weeks before. The participants will be randomly assigned to isokinetic, isotonic or isometric training groups. Outcome measures including isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma concentration of hsCRP, and the level of substance P in saliva will be collected at the beginning and 4 weeks after the training program. Statistical significant differences will be determined between the improvement of outcome measures of the isokinetic and the isotonic training groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

11.9 years

First QC Date

October 18, 2016

Last Update Submit

November 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Peak torque

    Isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s

    4 weeks

Secondary Outcomes (4)

  • Timed Up and Go test

    4 weeks

  • Short Form 36 (SF-36) questionnaire

    4 weeks

  • Oxford Hip/Knee Score

    4 weeks

  • The plasma concentration of hsCRP, and the level of substance P in saliva

    4 weeks

Study Arms (3)

Isokinetic training

EXPERIMENTAL

Ten times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec

Device: Isokinetic strengthening exercise

Isotonic training

ACTIVE COMPARATOR

Ten times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee

Device: Isotonic strengthening exercise

isometric training

PLACEBO COMPARATOR

home exercise education on isometric quadriceps strengthening on the day of out-patient appointment

Behavioral: isometric strengthening exercise

Interventions

Isokinetic strengthening exercise provides muscle training throughout the range of motion of a joint at a pre-set constant speed of angular velocity. It can be performed in an eccentric or concentric way in a controlled manner, and is evidenced to be an effective and safe training method in patients with anterior cruciate ligament reconstruction, burn injury, ankle instability, osteoarthritic knee, and chronic stroke in the past literatures.

Isokinetic training

Isotonic strengthening exercise keeps the tension remained unchanged during the muscle's length changing. As the muscle's force changes via the length-tension relationship during a contraction, an isotonic contraction will keep force constant while velocity changes. There are two types of isotonic contractions: (1) concentric and (2) eccentric. In a concentric contraction, the muscle tension rises to meet the resistance, then remains the same as the muscle shortens. In eccentric, the muscle lengthens due to the resistance being greater than the force the muscle is producing.

Isotonic training

home exercise education on isometric quadriceps strengthening on the day of out-patient appointment

isometric training

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • within one month of acute stroke
  • receive total hip/knee replacement within two to four weeks before

You may not qualify if:

  • cannot perform from sitting to standing
  • Body Mass Index \> 30
  • Lower limbs fracture history
  • Diabetic polyneuropathy
  • Cardiopulmonary diseases that impede exercise prescription
  • Impaired cognitive function
  • Infectious disease during the study period that may cause cytokine changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation

Taichung, 40705, Taiwan

RECRUITING

Related Publications (2)

  • Cheng YY, Chen CH, Wang SP. Isokinetic training of lower extremity during the early stage promote functional restoration in elder patients with disability after Total knee replacement (TKR) - a randomized control trial. BMC Geriatr. 2024 Feb 19;24(1):173. doi: 10.1186/s12877-024-04778-9.

  • Cheng YY, Liu CC, Lin SY, Lee CH, Chang ST, Wang SP. Comparison of the Therapeutic Effects Between Isokinetic and Isotonic Strength Training in Patients After Total Knee Replacement: A Prospective, Randomized Controlled Trial. Orthop J Sports Med. 2022 Jun 21;10(6):23259671221105852. doi: 10.1177/23259671221105852. eCollection 2022 Jun.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yuan-Yang Cheng, MD, PhD

    Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Yang Cheng, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Staff Doctor

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 19, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations