xml: <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/NCT05975229</url>
    </required_header>
    <id_info>
      <org_study_id>H02-16-12</org_study_id>
      <nct_id>NCT05975229</nct_id>
    </id_info>
    <brief_title>The Effects of a Knitting Program on Osteoarthritis Symptoms in Elderly Women</brief_title>
    <official_title>The Effects of an 8-week Knitting Program on Osteoarthritis Symptoms in Elderly Women: A Pilot Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université de Sherbrooke</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Ottawa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université de Sherbrooke</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness&#xD;
        of a knitting program in older females suffering from hand osteoarthritis (HOA) to evaluate&#xD;
        the acceptability of this intervention and assess the feasibility of a larger-scale RCT.&#xD;
  &#xD;
        It is a single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20&#xD;
        control, 20 experimental). Control participants are given an educational pamphlet and&#xD;
        assigned to a waiting list. The knitting program (-8-week duration) has two components:&#xD;
        bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5&#xD;
        remaining weekdays. Measures include knitting adherence (implementation outcomes) as well as&#xD;
        stiffness, pain, functional status, hand physical activity level, patient's global impression&#xD;
        of change, health-related quality of life, self-efficacy, and grip strength (clinical&#xD;
        outcomes measured throughout the 8-week program and 4 weeks after the intervention).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Exercise therapy is effective in reducing symptoms and disability associated with&#xD;
        hand osteoarthritis (HOA) but has low adherence. An intervention consisting in a meaningful&#xD;
        occupation, such as knitting, may improve adherence to treatment. This pilot randomized&#xD;
        controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program&#xD;
        in older females suffering from HOA to evaluate the acceptability of this intervention and&#xD;
        assess the feasibility of a larger-scale RCT.&#xD;
  &#xD;
        Methods: Single-blind, two-arm pilot RCT with a parallel group design with 40 participants&#xD;
        (20 control, 20 experimental). Control participants are given an educational pamphlet and&#xD;
        assigned to a waiting list. The knitting program (-8-week duration) has two components:&#xD;
        bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5&#xD;
        remaining weekdays. Measures included knitting adherence (implementation outcomes) as well as&#xD;
        stiffness, pain, functional status, hand physical activity level, patient's global impression&#xD;
        of change, health-related quality of life, self-efficacy, and grip strength (clinical&#xD;
        outcomes measured throughout the 8-week program and 4 weeks after the intervention).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2017</start_date>
    <completion_date type="Actual">December 20, 2017</completion_date>
    <primary_completion_date type="Actual">December 20, 2017</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>Single-blind, two-arm pilot RCT with a parallel group design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Stiffness</measure>
      <time_frame>daily for 12 weeks</time_frame>
      <description>0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dropout rates</measure>
      <time_frame>week 8</time_frame>
      <description>Assessed through a in-house questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to the knitting program</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>It was estimated using the logbook and the seniors club attendance sheet, whereby we divided the number of knitting sessions completed (at the club and at home) by the number of knitting sessions prescribed (56 sessions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain level</measure>
      <time_frame>Multiple times daily for 12 weeks</time_frame>
      <description>0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional status</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>Was assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). It consists in a 15-item scale, with items grouped into three subsections: A) pain intensity, B) stiffness severity, and C) hand functional status/difficulty in activities of daily living. For each item, scores range from 0 (no symptoms) to 4 (severe symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand physical activity</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>was measured using an adapted version of the 7-Day Physical Activity Readiness (PAR). It is in the form of a calendar in which participants record the duration (minutes per day) and frequency (days per week) of physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's global impression of change</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>It was assessed by asking patients if, following the knitting program, their condition was: 1) very much improved; 2) much improved; 3) minimally improved; 4) no change; 5) minimally worse; 6) much worse; 7) very much worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of life (QoL)</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>It was evaluated using the EuroQoL Index (EQ-5D-5L), which covers mobility, self-care, daily activities, Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>It was assessed using The Stanford Arthritis Self-Efficacy Scale, consisting in statements which patients rate on a ten-point scale ranging from 1 (very uncertain) to 10 (very certain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bilateral hand grip strength</measure>
      <time_frame>Baseline, week 4, week 8, and week 12</time_frame>
      <description>It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">37</enrollment>
    <condition>Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Educational pamphlet and knitting program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Educational pamphlet and assigned to a waiting list</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Knitting and education (pamphlet)</intervention_name>
      <description>Pamphlet and knitting program (-8-week duration). The knitting program has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays.</description>
      <arm_group_label>experimental</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education (pamphlet)</intervention_name>
      <description>Receive only the pamphlet, not the knitting program.</description>
      <arm_group_label>control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet the clinical and radiographic criteria of definite HOA set out by the American&#xD;
               College of Rheumatology (ACR) and have experienced pain symptoms for at least 3&#xD;
               months;&#xD;
  &#xD;
            -  Be a woman aged between 50 and 85 years; 3) have moderate to severe morning stiffness&#xD;
               (defined as a score ≥ 4 on a 10 cm visual analogue scale at the time of study entry;&#xD;
  &#xD;
            -  Display X-ray evidence of joint space narrowing of the hands;&#xD;
  &#xD;
            -  Have no previous experience with knitting or have not knitted in the last 6 months;&#xD;
  &#xD;
            -  Be available for sessions at the senior's club twice weekly;&#xD;
  &#xD;
            -  Be able to understand written and verbal English instructions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffered from other orthopedic or rheumatologic diseases (e.g., inflammatory&#xD;
               arthritis), or showed evidence of chondrocalcinosis;&#xD;
  &#xD;
            -  Had a history of finger joint surgery;&#xD;
  &#xD;
            -  Suffered from an acute disease, such as uncontrolled diabetes mellitus, untreated&#xD;
               hypertension, neurological deficits (motor or sensory), cognitive deficit or mental&#xD;
               health conditions;&#xD;
  &#xD;
            -  Were taking OA medication that was expected to change during the study period;&#xD;
  &#xD;
            -  Were receiving current rehabilitation treatments or any other pain-related treatment&#xD;
               besides medication for OA;&#xD;
  &#xD;
            -  Had received a corticosteroid injection in a finger joint within the last 6 months;&#xD;
  &#xD;
            -  Planned to move outside the region within 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Ottawa</name>
        <address>
          <city>Ottawa</city>
          <state>Quebec</state>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
      <investigator_full_name>Guillaume Léonard</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>hand</keyword>
    <keyword>osteoarthritis</keyword>
    <keyword>exercise</keyword>
    <keyword>knitting</keyword>
    <keyword>women</keyword>
    <keyword>pain</keyword>
    <keyword>stiffness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975229
  org study id: H02-16-12
  nct id: NCT05975229
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness
        of a knitting program in older females suffering from hand osteoarthritis (HOA) to evaluate
        the acceptability of this intervention and assess the feasibility of a larger-scale RCT.
  
        It is a single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20
        control, 20 experimental). Control participants are given an educational pamphlet and
        assigned to a waiting list. The knitting program (-8-week duration) has two components:
        bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5
        remaining weekdays. Measures include knitting adherence (implementation outcomes) as well as
        stiffness, pain, functional status, hand physical activity level, patient's global impression
        of change, health-related quality of life, self-efficacy, and grip strength (clinical
        outcomes measured throughout the 8-week program and 4 weeks after the intervention).
  Background: Exercise therapy is effective in reducing symptoms and disability associated with
        hand osteoarthritis (HOA) but has low adherence. An intervention consisting in a meaningful
        occupation, such as knitting, may improve adherence to treatment. This pilot randomized
        controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program
        in older females suffering from HOA to evaluate the acceptability of this intervention and
        assess the feasibility of a larger-scale RCT.
  
        Methods: Single-blind, two-arm pilot RCT with a parallel group design with 40 participants
        (20 control, 20 experimental). Control participants are given an educational pamphlet and
        assigned to a waiting list. The knitting program (-8-week duration) has two components:
        bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5
        remaining weekdays. Measures included knitting adherence (implementation outcomes) as well as
        stiffness, pain, functional status, hand physical activity level, patient's global impression
        of change, health-related quality of life, self-efficacy, and grip strength (clinical
        outcomes measured throughout the 8-week program and 4 weeks after the intervention).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-blind, two-arm pilot RCT with a parallel group design
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.
  measure: Stiffness
  time frame: daily for 12 weeks
  description: 0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness
  measure: Dropout rates
  time frame: week 8
  description: Assessed through a in-house questionnaire
  measure: Adherence to the knitting program
  time frame: Baseline, week 4, week 8, and week 12
  description: It was estimated using the logbook and the seniors club attendance sheet, whereby we divided the number of knitting sessions completed (at the club and at home) by the number of knitting sessions prescribed (56 sessions)
  measure: pain level
  time frame: Multiple times daily for 12 weeks
  description: 0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain
  measure: Functional status
  time frame: Baseline, week 4, week 8, and week 12
  description: Was assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). It consists in a 15-item scale, with items grouped into three subsections: A) pain intensity, B) stiffness severity, and C) hand functional status/difficulty in activities of daily living. For each item, scores range from 0 (no symptoms) to 4 (severe symptoms)
  measure: Hand physical activity
  time frame: Baseline, week 4, week 8, and week 12
  description: was measured using an adapted version of the 7-Day Physical Activity Readiness (PAR). It is in the form of a calendar in which participants record the duration (minutes per day) and frequency (days per week) of physical activity.
  measure: Patient's global impression of change
  time frame: Baseline, week 4, week 8, and week 12
  description: It was assessed by asking patients if, following the knitting program, their condition was: 1) very much improved; 2) much improved; 3) minimally improved; 4) no change; 5) minimally worse; 6) much worse; 7) very much worse
  measure: Health-related Quality of life (QoL)
  time frame: Baseline, week 4, week 8, and week 12
  description: It was evaluated using the EuroQoL Index (EQ-5D-5L), which covers mobility, self-care, daily activities, Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
  measure: Self-efficacy
  time frame: Baseline, week 4, week 8, and week 12
  description: It was assessed using The Stanford Arthritis Self-Efficacy Scale, consisting in statements which patients rate on a ten-point scale ranging from 1 (very uncertain) to 10 (very certain).
  measure: Bilateral hand grip strength
  time frame: Baseline, week 4, week 8, and week 12
  description: It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position
  arm group label: experimental
  arm group type: Experimental
  description: Educational pamphlet and knitting program
  arm group label: control
  arm group type: Other
  description: Educational pamphlet and assigned to a waiting list
  intervention type: Other
  intervention name: Knitting and education (pamphlet)
  description: Pamphlet and knitting program (-8-week duration). The knitting program has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays.
  arm group label: experimental
  intervention type: Other
  intervention name: Education (pamphlet)
  description: Receive only the pamphlet, not the knitting program.
  arm group label: control
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 50 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Université de Sherbrooke
  investigator full name: Guillaume Léonard
  investigator title: Professor
  mesh term: Osteoarthritis