<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481984</url>
  </required_header>
  <id_info>
    <org_study_id>Cukurova Uni. Neslihan G.</org_study_id>
    <nct_id>NCT04481984</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis</brief_title>
  <official_title>Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis: a Randomized Controlled, Single-blind, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of&#xD;
      the skin and internal organs. Hand involvement is one of the most observed musculoskeletal&#xD;
      involvements in patients with SSc, which can impact on general health, quality of life, and&#xD;
      psychological status. Hand exercise programs can help patients to improve not only hand&#xD;
      function but also general health status; nevertheless, further randomized control trials&#xD;
      (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the&#xD;
      effectiveness of home-based, self-administered exercise program for hands in patients with&#xD;
      SSc and demonstrate the improvements in general health status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study was designed as a single-blind, prospective, randomized controlled,&#xD;
      comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient&#xD;
      clinic of a university hospital, between July 2016-June 2019. Female patients with SSc who&#xD;
      fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis were included in&#xD;
      the study. Patients with neurological disorders, arthritis, myositis, amputation of fingers,&#xD;
      serious contracture resisting handgrip, and history of undergoing hand surgery were excluded&#xD;
      from the study. Patients were enrolled in the study after they signed the written informed&#xD;
      consent. Following the assessment of patients in terms of eligibility, patients were&#xD;
      randomized into an exercise and a control group. The computerized block randomization method&#xD;
      was used to randomize subjects into groups. Both groups were informed about systemic&#xD;
      sclerosis and they received the printed materials that include recommendations such as&#xD;
      avoiding cold and trauma. The treatment group participated in a single hand exercise training&#xD;
      (isometric hand exercise and self-administered stretching) applied by a physiatrist. They&#xD;
      additionally received the printable instructions for exercises. Compliance was assessed by a&#xD;
      checklist, which included all information on how to exercise and how many times to do them.&#xD;
      The investigators aimed to investigate the impact of hand exercise program on hand function&#xD;
      and demonstrate its influence on health status, quality of life, and psychological status of&#xD;
      patients with SSc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2016</start_date>
  <completion_date type="Actual">June 5, 2019</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled, Single-blind, Clinical Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>Before treatment to 8 weeks</time_frame>
    <description>Handgrip strength was measured by hydraulic hand dynamometer (JAMAR®,USA) according to the standard protocol, which calculates the average of three consecutive measurements of the dominant hand. The measurements were recorded as kilograms (kg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duruoz Hand Index</measure>
    <time_frame>Before treatment to 8 weeks</time_frame>
    <description>Duruoz Hand Index (DHI) is the 18-item questionnaire assessing hand skill in the kitchen, during dressing, while performing personal hygiene, while performing office tasks, and other general performances. Each item is rated from 0 (no difficulty) to 5 (impossible to do). The sum of the scores varies between 0 and 90. Higher scores indicate the impaired hand function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Systemic Sclerosis</condition>
  <condition>Scleroderma</condition>
  <condition>Hand Rheumatism</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training including isometric and stretching hand exercise was applied once by a physiatrist. A hand exercise ball was used for isometric exercise. Patients performed both stretching exercises and isometric exercises according to the training and printed materials. The home-based exercise program was implemented 7 days per week during an 8-week period. In addition, patients received recommendations such as avoiding cold exposure and trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients received care advice including avoiding cold exposure and trauma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-based Hand exercise</intervention_name>
    <description>Isometric exercise; patients squeezed a hand exercise ball for 60 seconds. This exercise repeated 15-times/3 set per day.&#xD;
Stretching exercises; self-administered stretching exercises were as follows; i) forearm supination and pronation, ii) wrist flexion and extension, iii) finger flexion, extension, and abduction iv) thumb flexion, extension, and abduction. These exercises repeated 10-times/2 set per day.</description>
    <arm_group_label>Exercise group</arm_group_label>
    <other_name>Rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Care advice</intervention_name>
    <description>Patients received care advice including avoiding cold exposure and trauma.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Female systemic sclerosis patients who fulfilled the 2013 ACR/EULAR classification&#xD;
        criteria for systemic sclerosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neurological disorders,&#xD;
&#xD;
          -  Arthritis,&#xD;
&#xD;
          -  Myositis,&#xD;
&#xD;
          -  Amputation of fingers,&#xD;
&#xD;
          -  Serious contracture resisting hand grip&#xD;
&#xD;
          -  History of undergoing hand surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients with Systemic sclerosis</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cukurova University</name>
      <address>
        <city>Adana</city>
        <state>Saricam</state>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.</citation>
    <PMID>29198478</PMID>
  </reference>
  <reference>
    <citation>Stefanantoni K, Sciarra I, Iannace N, Vasile M, Caucci M, Sili Scavalli A, Massimiani MP, Passi L, Maset L, Riccieri V. Occupational therapy integrated with a self-administered stretching program on systemic sclerosis patients with hand involvement. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):157-161. Epub 2016 Apr 14.</citation>
    <PMID>27087678</PMID>
  </reference>
  <reference>
    <citation>Mugii N, Hasegawa M, Matsushita T, Kondo M, Orito H, Yanaba K, Komura K, Hayakawa I, Hamaguchi Y, Ikuta M, Tachino K, Fujimoto M, Takehara K, Sato S. The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. J Rheumatol. 2006 Aug;33(8):1586-92.</citation>
    <PMID>16881115</PMID>
  </reference>
  <reference>
    <citation>Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859.</citation>
    <PMID>24812476</PMID>
  </reference>
  <reference>
    <citation>Liem SIE, Vliet Vlieland TPM, Schoones JW, de Vries-Bouwstra JK. The effect and safety of exercise therapy in patients with systemic sclerosis: a systematic review. Rheumatol Adv Pract. 2019 Dec 9;3(2):rkz044. doi: 10.1093/rap/rkz044. eCollection 2019.</citation>
    <PMID>31858074</PMID>
  </reference>
  <reference>
    <citation>Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.</citation>
    <PMID>27696703</PMID>
  </reference>
  <reference>
    <citation>Piga M, Tradori I, Pani D, Barabino G, Dessi A, Raffo L, Mathieu A. Telemedicine applied to kinesiotherapy for hand dysfunction in patients with systemic sclerosis and rheumatoid arthritis: recovery of movement and telemonitoring technology. J Rheumatol. 2014 Jul;41(7):1324-33. doi: 10.3899/jrheum.130912. Epub 2014 Jun 1.</citation>
    <PMID>24882841</PMID>
  </reference>
  <reference>
    <citation>Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):909-17. doi: 10.1002/acr.20448.</citation>
    <PMID>21312348</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Neslihan Gokcen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Systemic sclerosis</keyword>
  <keyword>Scleroderma</keyword>
  <keyword>Hand</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Exercise therapy</keyword>
  <keyword>Self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD may be shared with other researches</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Up to 6 months</ipd_time_frame>
    <ipd_access_criteria>Researchers who would like to access to individual participant data will be reviewed and approved by the principal investigator.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04481984/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04481984/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481984
org study id: Cukurova Uni. Neslihan G.
nct id: NCT04481984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of
      the skin and internal organs. Hand involvement is one of the most observed musculoskeletal
      involvements in patients with SSc, which can impact on general health, quality of life, and
      psychological status. Hand exercise programs can help patients to improve not only hand
      function but also general health status; nevertheless, further randomized control trials
      (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the
      effectiveness of home-based, self-administered exercise program for hands in patients with
      SSc and demonstrate the improvements in general health status.
The current study was designed as a single-blind, prospective, randomized controlled,
      comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient
      clinic of a university hospital, between July 2016-June 2019. Female patients with SSc who
      fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis were included in
      the study. Patients with neurological disorders, arthritis, myositis, amputation of fingers,
      serious contracture resisting handgrip, and history of undergoing hand surgery were excluded
      from the study. Patients were enrolled in the study after they signed the written informed
      consent. Following the assessment of patients in terms of eligibility, patients were
      randomized into an exercise and a control group. The computerized block randomization method
      was used to randomize subjects into groups. Both groups were informed about systemic
      sclerosis and they received the printed materials that include recommendations such as
      avoiding cold and trauma. The treatment group participated in a single hand exercise training
      (isometric hand exercise and self-administered stretching) applied by a physiatrist. They
      additionally received the printable instructions for exercises. Compliance was assessed by a
      checklist, which included all information on how to exercise and how many times to do them.
      The investigators aimed to investigate the impact of hand exercise program on hand function
      and demonstrate its influence on health status, quality of life, and psychological status of
      patients with SSc.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled, Single-blind, Clinical Study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Single
measure: Handgrip strength
time frame: Before treatment to 8 weeks
description: Handgrip strength was measured by hydraulic hand dynamometer (JAMAR®,USA) according to the standard protocol, which calculates the average of three consecutive measurements of the dominant hand. The measurements were recorded as kilograms (kg).
measure: Duruoz Hand Index
time frame: Before treatment to 8 weeks
description: Duruoz Hand Index (DHI) is the 18-item questionnaire assessing hand skill in the kitchen, during dressing, while performing personal hygiene, while performing office tasks, and other general performances. Each item is rated from 0 (no difficulty) to 5 (impossible to do). The sum of the scores varies between 0 and 90. Higher scores indicate the impaired hand function.
arm group label: Exercise group
arm group type: Experimental
description: The training including isometric and stretching hand exercise was applied once by a physiatrist. A hand exercise ball was used for isometric exercise. Patients performed both stretching exercises and isometric exercises according to the training and printed materials. The home-based exercise program was implemented 7 days per week during an 8-week period. In addition, patients received recommendations such as avoiding cold exposure and trauma.
arm group label: Control group
arm group type: Other
description: Patients received care advice including avoiding cold exposure and trauma.
intervention type: Other
intervention name: Home-based Hand exercise
description: Isometric exercise; patients squeezed a hand exercise ball for 60 seconds. This exercise repeated 15-times/3 set per day.
Stretching exercises; self-administered stretching exercises were as follows; i) forearm supination and pronation, ii) wrist flexion and extension, iii) finger flexion, extension, and abduction iv) thumb flexion, extension, and abduction. These exercises repeated 10-times/2 set per day.
arm group label: Exercise group
other name: Rehabilitation
intervention type: Other
intervention name: Care advice
description: Patients received care advice including avoiding cold exposure and trauma.
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
gender description: Female patients with Systemic sclerosis
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.
PMID: 29198478
citation: Stefanantoni K, Sciarra I, Iannace N, Vasile M, Caucci M, Sili Scavalli A, Massimiani MP, Passi L, Maset L, Riccieri V. Occupational therapy integrated with a self-administered stretching program on systemic sclerosis patients with hand involvement. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):157-161. Epub 2016 Apr 14.
PMID: 27087678
citation: Mugii N, Hasegawa M, Matsushita T, Kondo M, Orito H, Yanaba K, Komura K, Hayakawa I, Hamaguchi Y, Ikuta M, Tachino K, Fujimoto M, Takehara K, Sato S. The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. J Rheumatol. 2006 Aug;33(8):1586-92.
PMID: 16881115
citation: Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859.
PMID: 24812476
citation: Liem SIE, Vliet Vlieland TPM, Schoones JW, de Vries-Bouwstra JK. The effect and safety of exercise therapy in patients with systemic sclerosis: a systematic review. Rheumatol Adv Pract. 2019 Dec 9;3(2):rkz044. doi: 10.1093/rap/rkz044. eCollection 2019.
PMID: 31858074
citation: Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.
PMID: 27696703
citation: Piga M, Tradori I, Pani D, Barabino G, Dessi A, Raffo L, Mathieu A. Telemedicine applied to kinesiotherapy for hand dysfunction in patients with systemic sclerosis and rheumatoid arthritis: recovery of movement and telemonitoring technology. J Rheumatol. 2014 Jul;41(7):1324-33. doi: 10.3899/jrheum.130912. Epub 2014 Jun 1.
PMID: 24882841
citation: Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):909-17. doi: 10.1002/acr.20448.
PMID: 21312348
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Neslihan Gokcen
investigator title: Principal Investigator
mesh term: Rheumatic Diseases
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
sharing ipd: Yes
ipd description: All collected IPD may be shared with other researches
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Up to 6 months
ipd access criteria: Researchers who would like to access to individual participant data will be reviewed and approved by the principal investigator.
provided document: 
provided document: 