Clinical trial NCT03802578: 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
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Arthralgia
Keywords: Exercise
Hand function
Quality of Life
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: change of DASH questionnaire
timeFrame: Baseline, 6, 12, 24 weeks
Secondary outcomes:
measure: change of HAQ questionnaire
timeFrame: Baseline, 6, 12, 24 weeks
measure: change of Grip strength
timeFrame: Baseline, 6, 12, 24 weeks
measure: change of Pinch strength
timeFrame: Baseline, 6, 12, 24 weeks
measure: change of Dexterity
timeFrame: Baseline, 6, 12, 24 weeks
measure: change of Quality of Life
timeFrame: Baseline, 6, 12, 24 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Hospital of Athens 'Laiko'
state: Attica
city: Elefsina
country: Greece
facility: General Hospital of Elefsina 'Thriasio'
state: Attica
Study officials:
affiliation: National and Kapodistrian University of Athens
name: MARIA TEKTONIDOU, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.