ClinicalTrials.gg
Not yet recruitingNCT07804212Updated Sep 24, 2026

The Effectiveness of Strength Training and Self-management in Reducing Symptoms for Individuals With Knee Osteoarthritis

An interventional study of Strength Training in Osteoarthritis, sponsored by Pingtung Veterans General Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Primary conditionOsteoarthritis, KneeRegistry: OsteoarthritisReclassifiedWhy we changed it
Registry
Osteoarthritis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoarthritis, Knee
Why
  1. The study's title name Osteoarthritis, Knee, a narrower term within Osteoarthritis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Pingtung Veterans General Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
45 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 89 studies in Osteoarthritis, Knee with a site in Taiwan — 12 open to participants now, 14 under way, 3 of them phase 3. Osteoarthritis, Knee · Taiwan.

Planned enrollment
18th of 83
100 · median 60
Started
2026
with 2 others
No phase
49 of 89
6 open now
Primary completion
2027-05
later than 8 of 13 live
Registered
88th of 89
by date

Among the 89 studies in Osteoarthritis, Knee with a site in Taiwan, this one is the 18th largest by planned enrollment of the 83 interventional ones, is one of 3 that started in 2026, is one of 49 with no phase, reaches primary completion later than 8 of the 13 other live ones, and was the 88th registered.

By phase

89 studies; the count open now beside each. This study's row is marked.

No phasethis study49 · 6 open
Phase 49 · 0 open
Observational6 · 3 open
Phase 36 · 1 open
Phase 15 · 1 open
Phase 1/25 · 0 open
Phase 25 · 0 open
Phase 2/34 · 1 open

By the year they started

First in 2003; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 60 across the 83 interventional studies, 134 across the 6 observational. Of the 52 that completed or were terminated, 4 (8%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 89 studies in Osteoarthritis, Knee with a site in Taiwan, or all of them as a file.
02

Study summary

This study aims to investigate the effectiveness of an intervention combining strength training and self-management education in improving symptoms, sleep quality, emotional well-being, and quality of life in patients with knee osteoarthritis. This study employs a quasi-experimental design. Participants diagnosed with knee osteoarthritis were recruited from the outpatient orthopedics and rehabilitation departments of a public regional teaching hospital in southern Taiwan. They were randomly assigned to either an experimental group (n = 50) or a control group (n = 50). Due to the nature of the intervention, blinding was not feasible, and participants were aware of their group assignment.

The experimental group also participated in a home-based strength training program, while the control group received conventional osteoarthritis routine care. Data were collected at baseline, one month, and three months post-intervention during follow-up appointments.

Read the detailed description

Introduction Osteoarthritis is a chronic, progressive degenerative joint disease that predominantly affects the knee. Common clinical manifestations include joint pain, stiffness, and impaired physical function, which often lead to diminished sleep quality and psychological well-being, ultimately compromising the patient's overall quality of life. Osteoarthritis is a common degenerative disease that predominantly affects patients with Knee Osteoarthritis (KOA). Symptoms include swelling, pain, stiffness, and functional impairment of the lower limb joints. Severe cases can result in muscle atrophy and long-term disability, making it a major global health burden. WHO data indicates that while 365 million people had OA by 2019, the number surged to 528 million by late 2023, marking a 113% increase since 1990. The disease is particularly prevalent in the aging population, affecting 73% of men and 60% of women over the age of 55. Knee OA is the most common subtype, followed by hip OA. In Taiwan, the prevalence rate grew significantly from 7.9% in 1994 to 15% in 2015. Despite the rate remaining steady at 15% through 2024, the absolute number of people suffering from OA pain exceeds 3.5 million and continues to grow, severely impacting their daily quality of life. As the primary weight-bearing joint of the human body, the knee is highly susceptible to osteoarthritis (OA) due to constant mechanical stress and activity. Clinical manifestations typically include joint pain, stiffness, swelling, and impaired physical function. The development of OA is significantly associated with age and gender, particularly among individuals aged 45-50 and older. Given the global trends of population aging and increasing obesity, the impact of OA on physical function and quality of life has become more pronounced, subsequently escalating the socioeconomic burden. Consequently, investigating the symptoms and determinants of knee OA, alongside the current implementation of strength training and self-management interventions, has become a critical area of concern.

Pain symptoms associated with KOA lead to prolonged impairments across physical, psychological, and social domains, which subsequently compromise mental health, sleep quality, and general well-being. NICE (2020) identifies aging, female gender, and obesity as the primary risk factors for joint degeneration. The resulting pain and mobility limitations have enduring effects; persistent joint stiffness and discomfort often lead to a decline in sleep hygiene and psychological health, eventually evolving into chronic conditions that diminish quality of life in later years. Pain in KOA is a complex, subjective experience, and empirical evidence suggests a reciprocal relationship where deteriorating sleep quality is linked to the progressive worsening of arthritic pain. As a form of chronic musculoskeletal pain, it frequently disrupts nocturnal sleep, causing significant disturbances. Specifically, pain prolongs Stage 1 of non-rapid eye movement (NREM) sleep and interrupts the deeper Stages 3-4 (slow-wave sleep), leading to sleep patterns that are characteristically shallow, abbreviated, and fragmented, especially among the elderly population. In addition to pharmacological and surgical interventions, therapies such as acupuncture, Tai Chi, and yoga have been empirically validated for managing the progression and symptom severity of Knee Osteoarthritis (KOA). Significant early evidence indicates that strengthening the knee joint and its surrounding musculature can delay the radiographic progression of degeneration. Consequently, implementing structured and effective exercise regimens for symptom management and rehabilitation is crucial before surgical intervention becomes necessary. Such programs not only alleviate arthritic symptoms but also facilitate the maintenance of optimal sleep quality, mental health, and overall well-being. Defined as a planned, structured, and repetitive form of physical activity designed to enhance or maintain physical fitness, exercise therapy is widely utilized due to its feasibility and cost-effectiveness. Current international clinical guidelines advocate for exercise as a first-line treatment for KOA. The prescription of these exercise programs should be tailored to the specific joint location, pain phenotype, disease severity, comorbidities, and the patient's baseline physical condition. Given the high prevalence of KOA, there is a critical need for accessible and cost-effective strategies; therefore, home-based exercise programs should be prioritized.

In a systematic review and meta-analysis by Guo et al. (2022), 15 clinical trials identified from databases such as PubMed, EBSCO, SportDiscus, Medline, and Web of Science (2000-2022) were analyzed. The findings revealed that structured exercise programs significantly improved pain, stiffness, and physical function in patients with KOA. Similarly, a Cochrane review of 55 studies across five major databases (MEDLINE, EMBASE, CENTRAL, CINAHL, and PEDro) concluded that exercise interventions yield moderate to significant benefits in pain reduction and functional improvement. Resistance training, in particular, has been shown to effectively alleviate pain. However, experts caution that ineffective or improperly supervised exercise regimens may exacerbate symptoms, resulting in poor clinical outcomes and diminished patient adherence; thus, the modality and frequency of exercise must be meticulously designed and managed (Peeler \& Ripat, 2018). Despite these global findings, local research in Taiwan concerning the interplay between KOA symptoms, sleep quality, emotional well-being, and the efficacy of strength training and self-management remains sparse.

Study purpose This study aims to evaluate the effectiveness of a combined strength training and self-management intervention in enhancing the symptomatic, psychological, and functional outcomes of patients with knee osteoarthritis.

Study design A quasi-experimental design will be employed in this study to evaluate the effectiveness of the intervention. Data will be gathered through structured questionnaires administered both before and after the strength training program. The assessment will focus on several key variables: osteoarthritis symptoms, sleep quality, emotional well-being, and quality of life. These pre- and post-intervention measures will then be analyzed to determine the impact of the strength training program on the participants. The target population for this study will consist of patients with knee osteoarthritis (KOA). Consecutive sampling will be utilized to recruit participants from the orthopedic and rehabilitation outpatient departments of a public regional teaching hospital in southern Taiwan. Participants will be required to complete basic demographic forms and structured questionnaires both before and after the intervention.

Study Setting, Participants, Sample Size Estimation Inclusion criteria will be as follows: patients aged 45 or older diagnosed with symptomatic KOA by a physician, who are conscious, have normal hearing, and are capable of effective communication. Conversely, the exclusion criteria will include patients with severe inflammatory arthritis; those awaiting or having undergone unilateral or bilateral total knee arthroplasty; individuals with contraindications to exercise therapy; those who have received physical therapist-led exercise therapy or knee injections within the past month; and individuals diagnosed with psychiatric or cognitive impairments. Sample size estimation will be performed using G*Power 3.1.9.4 software, employing the "Means: Difference between two independent means (two groups)" test mode. With the effect size set at a medium level of 0.6, a significance level (alpha) of 0.05, and a power of 0.80 (Cohen, 1988), the analysis indicates a minimum required sample size of 90 participants. Accounting for an estimated attrition rate of 10%, the total sample size will be increased to 100 participants, with 50 individuals assigned to the experimental group and 50 to the control group.

Study Recruitment Process During recruitment at the orthopedic or rehabilitation outpatient departments, the study's objectives and the group assignment process will be explained to potential participants. After obtaining signed informed consent, participants will be randomly assigned to either the experimental or control group using computer-generated randomization. Participants will be aware of their group assignment. Both groups will receive health education through a "Knee Osteoarthritis Self-Management Course" (with an online instructional URL provided for home viewing). The experimental group will additionally receive a "Home-Based Strength Training" intervention, while the control group will maintain conventional routine care. Prior to the intervention, baseline data will be collected from both groups. The demographic data will encompass age, gender, education level, marital status, religious beliefs, occupation, level of social support, smoking and alcohol history, history of knee osteoarthritis and pain, medication history, and comorbidities. The assessment scales will include the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), PSQI, HADS, and the EQ-5D-3L.

1. Intervention for the Experimental Group: Participants in the experimental group will receive a 23-30 minute demonstration and explanation of the "Home-Based Strength Training" program. The session will begin with warm-up exercises. All movements will be performed slowly and steadily, avoiding rapid or sudden motions to prevent injury. The intervention consists of three primary components:

  1. Knee Muscle Endurance Training (Two sets): Step-ups and Step-downs: Participants will perform 20 steps each, using stairs or a platform. Starting with feet shoulder-width apart, participants will step up ensuring the knee aligns with the toes without overextending. The movement will be driven by the anterior leg muscles. For step-downs, participants will descend slowly, maintaining knee-toe alignment and stability. Sit-to-Stand Exercises: Participants will perform 10 repetitions per set. Using a stable chair of appropriate height (thighs and calves at a 70-90 degree angle), participants will stand up by driving through the legs while keeping the back straight and knees slightly flexed upon standing. Frequency: 3 times per week, 8 sets per session, with a 2-minute rest between sets.
  2. Level-Ground Walking: Participants will walk for 30 minutes per session, 3 times per week, on flat, safe surfaces using appropriate footwear. The technique emphasizes a natural heel-to-toe strike, coordinated arm swinging, and steady breathing.
  3. Range of Motion (ROM) and Flexibility Exercises: Knee Extension: While seated with the back against the chair, participants will slowly lift one leg until the knee reaches 160-180 degrees of extension, then pull the heel back toward the seat. (Held for 20 seconds, 10 reps per set, 3 times per day).

Quadriceps Stretch: While standing and holding a stable surface for balance, participants will pull one ankle toward the glutes until tension is felt in the anterior thigh. (Held for 30 seconds, 10 reps per set, 3 times per day).

After the initial demonstration, participants will demonstrate the exercises back to the researcher. The researcher will provide corrections until the movements are performed correctly. Participants will be instructed to record their completion in an exercise log. Follow-up assessments will occur during the second clinic visit (1 month post-intervention) and the third clinic visit (2 months post-intervention), utilizing the WOMAC, PSQI, HADS, and EQ-5D-3L scales. Additionally, the researcher will conduct two telephone follow-ups and home visits as needed during the study period to monitor adherence.

2. Control Group: The control group will receive conventional routine care on knee osteoarthritis self-care. Follow-up assessments will be conducted during the second clinic visit (1 month post-enrollment) and the third clinic visit (2 months post-enrollment). During these visits, data will be collected using the WOMAC Osteoarthritis Index, PSQI, HADS, and the EQ-5D-3L scale.

Ethical Considerations

  1. Data collection will commence only after the study protocol has been reviewed and approved by the hospital's Institutional Review Board (IRB No: PTVGH26-CT4-04) and administrative permission for recruitment has been obtained.
  2. Prior to recruitment, the attending physician will evaluate the patient's condition to ensure they meet the inclusion criteria. The physician will continue to monitor the participant throughout data collection. If a participant's condition fluctuates or deteriorates, data collection will be terminated immediately, and the individual will be excluded from the study.
  3. The study's objectives, methods, and procedures will be explained in detail to each participant and their family members. Data will only be collected after they have fully understood the information and signed the informed consent form.
  4. Participants will be informed of their right to refuse participation or withdraw from the study at any time without any adverse impact on the quality of their medical treatment or nursing care.
  5. To ensure confidentiality, all participant data will be processed using a coding system. Except for investigations required by law, participants' names and privacy-including collected data, test results, and diagnoses-will be strictly protected. All data will be destroyed after being securely stored for five years.
  6. If the research findings are published for academic purposes, participants' privacy (including names and medical record numbers) will remain confidential and will not be disclosed individually.

Data Processing and Statistical Analysis The demographic data and questionnaire responses collected in this study will be coded and entered into a computer database. Data management and statistical analysis will be performed using IBM SPSS Statistics version 26.0. The significance level for all statistical analyses is set at alpha = 0.05. In addition to descriptive statistics, the choice between parametric or non-parametric methods for correlational and inferential analyses will be determined after assessing the data distribution. A normality test (e.g., Shapiro-Wilk or Kolmogorov-Smirnov test) will be conducted to confirm whether the collected data follow a normal distribution.

Expected Contributions This study will employ a quasi-experimental design to evaluate the effectiveness of a strength training intervention in alleviating symptoms and improving sleep quality, emotional health, and overall quality of life among patients with knee osteoarthritis. The findings are expected to demonstrate the clinical significance of a feasible, home-based strength training program in reducing symptom severity and enhancing the well-being of KOA patients in Taiwan. Furthermore, the results will be prepared for publication in international peer-reviewed journals to facilitate knowledge dissemination within the global academic community and the general public. Beyond its academic contributions, this study will provide evidence-based insights to help healthcare authorities optimize treatment, care, and management protocols for KOA, ultimately contributing to reduced national healthcare expenditures. Finally, this program empowers patients to proactively self-manage their symptoms and promote long-term functional independence.

03

Conditions studied

  • Osteoarthritis

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Keywords

  • strength training
  • self-management
  • knee osteoarthritis
04

In context

Osteoarthritis, Knee Reclassified

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 100 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Pingtung Veterans General Hospital as lead sponsor.

Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 45 or older
  • Diagnosed with symptomatic knee osteoarthritis by a physician
  • Normal hearing and able to communicate effectively

Exclusion criteria

Exclusion Criteria:

  • Severe inflammatory arthritis
  • Pending or previous unilateral or bilateral total knee replacement
  • to exercise therapy
  • Received physical therapy or knee injections in the past month
  • Psychiatric or cognitive impairments
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Strength Training Group

    A structured home-based strength training program consisting of knee endurance exercises, sit-to-stand transitions, walking, and range-of-motion (ROM) exercises. The intervention is performed three times per week for 8 weeks. To ensure exercise fidelity and safety, the 'teach-back' method is utilized during initial instruction, and participants maintain a daily exercise log to monitor compliance.

    Other: Strength Training

  • Other
    conventional osteoarthritis routine care

    The group will receive conventional osteoarthritis routine care. Follow-up assessments will be conducted during the second clinic visit (1 month post-enrollment) and the third clinic visit (2 months post-enrollment).

    Other: Strength Training

Interventions

  • OtherStrength Training

    A structured home-based strength training program consisting of knee endurance exercises, sit-to-stand transitions, walking, and range-of-motion (ROM) exercises. The intervention is performed three times per week for 8 weeks. To ensure exercise fidelity and safety, the 'teach-back' method is utilized during initial instruction, and participants maintain a daily exercise log to monitor compliance.

07

What researchers measure

Primary outcomes

  1. Emotional well-being measured by the HADS

    The HADS consists of anxiety and depression subscales, each with seven items and a maximum score of 21; higher scores indicate greater symptom severity.

    Time frame: Baseline, 1 month, and 2 months

  2. Sleep quality measured by the PSQ

    The PSQI comprises seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.

    Time frame: Baseline, 1 month, and 2 months

  3. Quality of life measured by the EQ-5D-3L

    EQ-5D-3L comprises two components: (1) the EQ-5D health index. A maximum total score of 15; lower scores indicate better health-related quality of life. (2) EQ-VAS uses a visual analog scale with a maximum score of 100.

    Time frame: Baseline, 1 month, and 2 months

  4. OA symptoms measured by the WOMAC

    WOMAC: The Mandarin Chinese version uses a 100-mm visual analog scale, with ends representing opposite symptoms like "no pain" to "very painful," "no stiffness" to "very stiff," and "no difficulty" to "very difficult." Scores range from 0 to 100 per question, with pain up to 500, stiffness up to 200, and activity up to 1700 points.

    Time frame: Baseline, 1 month, and 2 months

08

Study locations

1 site
09

References and documents

Individual participant data

Plan to share: Yes — IPD that underlies the results in a publication.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 7 months is below that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Sep 4, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
May 11, 2027
CompletionEst.
May 11, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07804212
Lead sponsor
Pingtung Veterans General Hospital
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 11, 2027 (estimated)
Completion
May 11, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Ching-Ju Chen, PhD
Contact
FT096@fy.edu.tw
+886923911285

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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