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

Primary Purpose

Systemic Lupus Erythematosus, Arthralgia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
HAND EXERCISE
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Systemic Lupus Erythematosus focused on measuring Exercise, Hand function, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Athens 'Laiko'
  • General Hospital of Elefsina 'Thriasio'

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EXERCISE GROUP

CONTROL GROUP

Arm Description

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.

Patients in the control group continued their usual medical care.

Outcomes

Primary Outcome Measures

change of DASH questionnaire
Hand function was measured with DASH Questionnaire

Secondary Outcome Measures

change of HAQ questionnaire
Hand function was measured with HAQ Questionnaire
change of Grip strength
Grip strength was measured with Jamar Dynamometer
change of Pinch strength
Pinch strength was measured with Jamar pinch gauge
change of Dexterity
Dexterity was measured with Purdue Pegboard test
change of Quality of Life
Quality of Life was measured with LupusQoL Questionnaire

Full Information

First Posted
January 10, 2019
Last Updated
January 10, 2019
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03802578
Brief Title
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Arthralgia
Keywords
Exercise, Hand function, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXERCISE GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
Patients in the control group continued their usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
HAND EXERCISE
Primary Outcome Measure Information:
Title
change of DASH questionnaire
Description
Hand function was measured with DASH Questionnaire
Time Frame
Baseline, 6, 12, 24 weeks
Secondary Outcome Measure Information:
Title
change of HAQ questionnaire
Description
Hand function was measured with HAQ Questionnaire
Time Frame
Baseline, 6, 12, 24 weeks
Title
change of Grip strength
Description
Grip strength was measured with Jamar Dynamometer
Time Frame
Baseline, 6, 12, 24 weeks
Title
change of Pinch strength
Description
Pinch strength was measured with Jamar pinch gauge
Time Frame
Baseline, 6, 12, 24 weeks
Title
change of Dexterity
Description
Dexterity was measured with Purdue Pegboard test
Time Frame
Baseline, 6, 12, 24 weeks
Title
change of Quality of Life
Description
Quality of Life was measured with LupusQoL Questionnaire
Time Frame
Baseline, 6, 12, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA TEKTONIDOU, Ass. Prof
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Athens 'Laiko'
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Elefsina 'Thriasio'
City
Elefsina
State/Province
Attica
ZIP/Postal Code
19600
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31958285
Citation
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.
Results Reference
derived

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

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