Background <p>Knee osteoarthritis (KOA) is one of the most prevalent health issues, affecting approximately 67% of women over 60&#xa0;years old. Clinical guidelines recommend individualized muscle training to treat this condition. However, a lack of human and financial resources hinders the delivery of this treatment. In response to this limitation, group training may be an alternative. Although a few studies have compared group and individual exercise for knee OA, none have tested the non-inferiority of group-delivered circuit training specifically in elderly women. Therefore, this study aims to compare the non-inferiority of a group-delivered muscle training program to the same individually delivered training in clinical and functional aspects in elderly women with KOA.</p> Methods <p>This is a randomized controlled non-inferiority trial with two arms, parallel groups, blinded evaluator, conducted in Petrolina—PE, evaluating women aged 60 or older. Participants randomly assigned will undergo an 8-week training, either in individual sessions (control group—IB) or as part of a group (intervention group—GB) of four participants, supervised by a physical therapist. Blind assessments at baseline, immediately post-intervention, and 4 weeks post-intervention will include feasibility, safety, and satisfaction analysis of the training program; pain; quality of life; and physical function. Data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 22. Estimated marginal means of each clinical and functional outcome for both groups (IB and GB) will be compared using mixed-effects generalized linear models. The primary analysis will test our main hypothesis that group training is non-inferior to individualized training regarding the primary outcome: relative reduction (%) in the WOMAC questionnaire pain subscale. Confidence intervals of 95% will be calculated. A significance level of <i>p</i> &lt; 0.05 will be adopted in all analyses.</p> Discussion <p>Expected results suggest that a group-based approach is not inferior to an individual one in this population.</p> Trial registration <p>Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-5bq9jh3. Registered on 18 August 2023. Link: <a href="http://www.ensaiosclinicos.gov.br">http://www.ensaiosclinicos.gov.br</a>; Universal Trial Number (UTN) of World Health Organization: U1111-1289–2580.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Group-based versus individual-based circuit training in elderly women with knee osteoarthritis: study protocol for a non-inferiority randomized controlled trial

  • Clécio Lima-Lopes,
  • Amanda Virginia Souza Lima Lopes,
  • Rebeca Cajueiro Azevedo,
  • Francis Trombini-Souza,
  • Tarcísio Fulgêncio Alves da Silva

摘要

Background

Knee osteoarthritis (KOA) is one of the most prevalent health issues, affecting approximately 67% of women over 60 years old. Clinical guidelines recommend individualized muscle training to treat this condition. However, a lack of human and financial resources hinders the delivery of this treatment. In response to this limitation, group training may be an alternative. Although a few studies have compared group and individual exercise for knee OA, none have tested the non-inferiority of group-delivered circuit training specifically in elderly women. Therefore, this study aims to compare the non-inferiority of a group-delivered muscle training program to the same individually delivered training in clinical and functional aspects in elderly women with KOA.

Methods

This is a randomized controlled non-inferiority trial with two arms, parallel groups, blinded evaluator, conducted in Petrolina—PE, evaluating women aged 60 or older. Participants randomly assigned will undergo an 8-week training, either in individual sessions (control group—IB) or as part of a group (intervention group—GB) of four participants, supervised by a physical therapist. Blind assessments at baseline, immediately post-intervention, and 4 weeks post-intervention will include feasibility, safety, and satisfaction analysis of the training program; pain; quality of life; and physical function. Data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 22. Estimated marginal means of each clinical and functional outcome for both groups (IB and GB) will be compared using mixed-effects generalized linear models. The primary analysis will test our main hypothesis that group training is non-inferior to individualized training regarding the primary outcome: relative reduction (%) in the WOMAC questionnaire pain subscale. Confidence intervals of 95% will be calculated. A significance level of p < 0.05 will be adopted in all analyses.

Discussion

Expected results suggest that a group-based approach is not inferior to an individual one in this population.

Trial registration

Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-5bq9jh3. Registered on 18 August 2023. Link: http://www.ensaiosclinicos.gov.br; Universal Trial Number (UTN) of World Health Organization: U1111-1289–2580.