Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:09 AM
Study NCT ID:
NCT07445568
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain
Sponsor:
Universidad del Valle de México, Campus Cuernavaca
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOA-ISO01
Brief Summary:
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.
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.
Detailed Description:
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.
As a pilot study, results are intended to inform the design and sample size estimation of future adequately powered randomized controlled trials evaluating low-cost, home-based rehabilitation strategies for older adults with knee osteoarthritis.
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.
As a pilot study, results are intended to inform the design and sample size estimation of future adequately powered randomized controlled trials evaluating low-cost, home-based rehabilitation strategies for older adults with knee osteoarthritis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: