Home-based Quadriceps Isometric Exercise as a First-Line Rehabilitation Strategy for Knee Osteoarthritis Pain in Community-Dwelling Older Adults: A Randomized Factorial Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)
研究概览
简要总结
Knee osteoarthritis is a common cause of pain and reduced mobility in older adults. Many people have limited access to supervised rehabilitation programs, highlighting the need for simple and safe home-based treatment options.
This study evaluates whether a brief home-based quadriceps isometric exercise program can reduce knee pain in community-dwelling older adults. Participants perform short daily muscle contractions of the thigh muscles for 28 days. In addition, participants are assigned to receive one of four topical formulations (placebo, cannabidiol, arnica, or a combination of cannabidiol and arnica) to explore whether these products modify the exercise response.
The primary outcome is change in knee pain intensity measured using a visual analog scale. Secondary outcomes include adherence and safety. This pilot study aims to assess the feasibility, safety, and preliminary effectiveness of this low-cost and easily accessible strategy to inform future larger clinical trials.
详细描述
This study is a prospective randomized 4×2 factorial pilot trial conducted in community-dwelling older adults with symptomatic knee osteoarthritis. The purpose is to evaluate the feasibility, safety, and preliminary effectiveness of a brief home-based quadriceps isometric exercise program for short-term pain reduction, and to explore whether topical cannabidiol (CBD), arnica, or their combination modify the exercise response.
Participants are randomly assigned to one of four topical treatment groups (placebo, CBD, arnica, or CBD + arnica) and stratified to either an exercise or no-exercise condition, resulting in eight factorial subgroups. Randomization is computer-generated with allocation concealment using sequentially numbered opaque sealed envelopes.
The intervention period lasts 28 days. Participants allocated to the exercise condition perform daily quadriceps isometric contractions at home consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, requiring approximately 6 minutes per day. Topical formulations are applied twice daily to the affected knee. Adherence is monitored using daily logs.
The primary outcome is change in knee pain intensity measured using a Visual Analog Scale (VAS) at day 28. Secondary outcomes include feasibility indicators (adherence and retention), safety (adverse events), and exploratory changes in anthropometric and body composition measures.
Analyses are exploratory and include factorial ANCOVA adjusted for baseline values to estimate main effects of exercise and topical treatment, as well as interaction effects. Effect sizes are calculated to aid clinical interpretation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants were blinded to topical treatment allocation through identical packaging and appearance of formulations. Investigators responsible for data collection were not involved in treatment assignment. Exercise allocation could not be blinded due to the nature of the intervention, and outcomes were self-reported.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 65 years or older
- •Clinical diagnosis of chronic knee osteoarthritis according to American College of Rheumatology criteria
- •Knee pain for ≥3 months
- •Baseline knee pain intensity ≥4 on a 10-cm Visual Analog Scale (VAS)
- •Ability to walk independently with or without assistive devices
- •Ability to understand study procedures and provide written informed consent
排除标准
- •Recent knee surgery or intra-articular injection within the last 3 months
- •Planned knee surgery during the study period
- •Severe neurological or cardiovascular conditions limiting exercise participation
- •Skin lesions or hypersensitivity to topical formulations
- •Current use of topical analgesics on the target knee
- •Cognitive impairment preventing adherence to the protocol
- •Participation in another clinical trial within the last 30 days
研究组 & 干预措施
Arm Title Placebo Topical + Isometric Exercise
Participants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days.
干预措施: Placebo Topical Gel (Drug)
Arm Title Placebo Topical + Isometric Exercise
Participants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days.
干预措施: Home-based Quadriceps Isometric Exercise (Behavioral)
Placebo Topical Only
Participants received placebo topical gel twice daily without exercise.
干预措施: Placebo Topical Gel (Drug)
CBD Topical + Isometric Exercise
Participants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: Cannabidiol (CBD) Topical Gel (Drug)
CBD Topical + Isometric Exercise
Participants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: Home-based Quadriceps Isometric Exercise (Behavioral)
CBD Topical Only
Participants received cannabidiol topical formulation twice daily without exercise.
干预措施: Cannabidiol (CBD) Topical Gel (Drug)
Arnica Topical + Isometric Exercise
Participants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: Arnica montana Topical Gel (Drug)
Arnica Topical + Isometric Exercise
Participants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: Home-based Quadriceps Isometric Exercise (Behavioral)
Arnica Topical Only
Participants received Arnica montana topical formulation twice daily without exercise.
干预措施: Arnica montana Topical Gel (Drug)
CBD + Arnica Topical + Exercise
Participants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: Home-based Quadriceps Isometric Exercise (Behavioral)
CBD + Arnica Topical + Exercise
Participants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.
干预措施: CBD + Arnica Topical Gel (Drug)
CBD + Arnica Topical Only
Participants received combined cannabidiol and Arnica montana topical formulation twice daily without exercise.
干预措施: CBD + Arnica Topical Gel (Drug)
结局指标
主要结局
Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)
时间窗: Baseline to Day 28
Knee pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). The primary endpoint is the change from baseline to Day 28. Higher scores indicate greater pain.
次要结局
- Change from baseline in quadriceps isometric strength(Baseline to Day 28)
- Change from baseline in body composition(Baseline to Day 28)
- Exercise and topical treatment adherence(Throughout the 28-day intervention)
- Adverse events(Baseline to Day 28)