NCT03802578

Brief Summary

A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30). Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

September 28, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

January 10, 2019

Last Update Submit

November 22, 2024

Conditions

Systemic Lupus ErythematosusArthralgia

Keywords

ExerciseHand functionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • change of DASH questionnaire

    Hand function was measured with DASH Questionnaire

    Baseline, 6, 12, 24 weeks

Secondary Outcomes (5)

  • change of HAQ questionnaire

    Baseline, 6, 12, 24 weeks

  • change of Grip strength

    Baseline, 6, 12, 24 weeks

  • change of Pinch strength

    Baseline, 6, 12, 24 weeks

  • change of Dexterity

    Baseline, 6, 12, 24 weeks

  • change of Quality of Life

    Baseline, 6, 12, 24 weeks

Study Arms (2)

EXERCISE GROUP

EXPERIMENTAL

Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care.

Behavioral: HAND EXERCISE

CONTROL GROUP

NO INTERVENTION

Patients in the control group continued their usual medical care.

Interventions

HAND EXERCISEBEHAVIORAL
EXERCISE GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SLE patients fulfilling the SLICC classification criteria
  • Upper limb arthralgias
  • DASH score\>10
  • Stable drug regimen≥3 months

You may not qualify if:

  • Hand fracture or surgery in last 6 months
  • Physiotherapy program in last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Athens 'Laiko'

Athens, Attica, 11527, Greece

Location

General Hospital of Elefsina 'Thriasio'

Elefsina, Attica, 19600, Greece

Location

Related Publications (1)

  • Keramiotou K, Anagnostou C, Kataxaki E, Galanos A, Sfikakis PP, Tektonidou MG. The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial. RMD Open. 2020 Jan;6(1):e001141. doi: 10.1136/rmdopen-2019-001141.

    PMID: 31958285DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthralgiaMotor Activity

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • MARIA TEKTONIDOU, Ass. Prof

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor Medical School

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

September 28, 2016

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)