The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients

January 10, 2019 updated by: Maria Tektonidou, National and Kapodistrian University of Athens

The Impact of Exercise on Hand Function, on Activities of Daily Living (ADLs) Performance and Quality of Life of Patients With Systemic Lupus Erythematosus (SLE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was evaluated. Sixty two patients who met the inclusion criteria [age>18, upper limb arthralgias, and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score>10)] 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens 'Laiko'
      • Elefsina, Attica, Greece, 19600
        • General Hospital of Elefsina 'Thriasio'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXERCISE GROUP
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
No Intervention: CONTROL GROUP
Patients in the control group continued their usual medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of DASH questionnaire
Time Frame: Baseline, 6, 12, 24 weeks
Hand function was measured with DASH Questionnaire
Baseline, 6, 12, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of HAQ questionnaire
Time Frame: Baseline, 6, 12, 24 weeks
Hand function was measured with HAQ Questionnaire
Baseline, 6, 12, 24 weeks
change of Grip strength
Time Frame: Baseline, 6, 12, 24 weeks
Grip strength was measured with Jamar Dynamometer
Baseline, 6, 12, 24 weeks
change of Pinch strength
Time Frame: Baseline, 6, 12, 24 weeks
Pinch strength was measured with Jamar pinch gauge
Baseline, 6, 12, 24 weeks
change of Dexterity
Time Frame: Baseline, 6, 12, 24 weeks
Dexterity was measured with Purdue Pegboard test
Baseline, 6, 12, 24 weeks
change of Quality of Life
Time Frame: Baseline, 6, 12, 24 weeks
Quality of Life was measured with LupusQoL Questionnaire
Baseline, 6, 12, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: MARIA TEKTONIDOU, Ass. Prof, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 680/10-06-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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