Older Adults (60 - 85 Years Old)KOA-ISO01NCT07445568
Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain
A study testing Cannabidiol (CBD) Topical Gel, Arnica montana Topical Gel and Home-based Quadriceps Isometric Exercise in people with Older Adults (60 - 85 Years Old) and OA Knee, run by Universidad del Valle de México, Campus Cuernavaca at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Older Adults (60 - 85 Years Old), OA Knee
- What is being tested?
- Cannabidiol (CBD) Topical Gel, Arnica montana Topical Gel and Home-based Quadriceps Isometric Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional de Alta Especialidad "Centenario de la Revolución Mexicana" - ISSSTE, Servicio de Alimentación y Nutrición Clínica
Xochitepec, Morelos, 62790
About this study
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
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.
Read the 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.
- Conditions
- Older Adults (60 - 85 Years Old), OA Knee
- Being tested
- Placebo Topical Gel, Cannabidiol (CBD) Topical Gel, Arnica montana Topical Gel, Home-based Quadriceps Isometric Exercise, CBD + Arnica Topical Gel
- Keywords
- Isometric exercise, Home-based rehabilitation, Physical therapy, Non-pharmacological treatment, Pain management, Topical cannabidiol, Arnica montana
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Topical GelDrug
Placebo topical formulation without active pharmacological ingredients, applied twice daily to the affected knee for 28 days.
Cannabidiol (CBD) Topical GelDrug
Topical cannabidiol formulation applied twice daily to the affected knee for 28 days.
Arnica montana Topical GelDrug
Topical Arnica montana formulation applied twice daily to the affected knee for 28 days.
Home-based Quadriceps Isometric ExerciseBehavioural
Daily home-based quadriceps isometric exercise protocol consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, performed for 28 days.
CBD + Arnica Topical GelDrug
combined cannabidiol and arnica formulation applied twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm Title Placebo Topical + Isometric Exercise | Experimental | Participants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days. Receives: Drug: Placebo Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise |
| Placebo Topical Only | Experimental | Participants received placebo topical gel twice daily without exercise. Receives: Drug: Placebo Topical Gel |
| CBD Topical + Isometric Exercise | Experimental | Participants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise. Receives: Drug: Cannabidiol (CBD) Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise |
| CBD Topical Only | Experimental | Participants received cannabidiol topical formulation twice daily without exercise. Receives: Drug: Cannabidiol (CBD) Topical Gel |
| Arnica Topical + Isometric Exercise | Experimental | Participants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise. Receives: Drug: Arnica montana Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise |
| Arnica Topical Only | Experimental | Participants received Arnica montana topical formulation twice daily without exercise. Receives: Drug: Arnica montana Topical Gel |
| CBD + Arnica Topical + Exercise | Experimental | Participants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise. Receives: Behavioral: Home-based Quadriceps Isometric Exercise; Drug: CBD + Arnica Topical Gel |
| CBD + Arnica Topical Only | Experimental | Participants received combined cannabidiol and Arnica montana topical formulation twice daily without exercise. Receives: Drug: CBD + Arnica Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)
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.
Measured: Baseline to Day 28
Secondary outcomes (4)
Change from baseline in quadriceps isometric strength
Maximal voluntary isometric quadriceps strength will be measured using handheld dynamometry. The outcome will be expressed as peak force (kg or N). Change from baseline to Day 28 will be analyzed.
Measured: Baseline to Day 28
Change from baseline in body composition
Lean mass and fat mass will be assessed using bioelectrical impedance analysis. Change from baseline to Day 28 will be evaluated.
Measured: Baseline to Day 28
Exercise and topical treatment adherence
Adherence will be calculated as the percentage of prescribed sessions/applications completed according to daily logs.
Measured: Throughout the 28-day intervention
Adverse events
Frequency and type of adverse events related to topical formulations or exercise will be recorded.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (60 - 85 Years Old)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants were randomized to a 4×2 factorial design. Four topical treatment conditions (placebo, cannabidiol, arnica, cannabidiol plus arnica) were combined with two exercise conditions (home-based quadriceps isometric exercise vs no exercise), resulting in eight parallel intervention groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle de México, Campus Cuernavaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445568
- Sponsor's protocol ID
- UVM-KOAISO-01-2025
- Acronym
- KOA-ISO01
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional privacy policies and protection of patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07445568
- Acronym / sponsor ID
- KOA-ISO01 / UVM-KOAISO-01-2025
- Conditions
- Older Adults (60 - 85 Years Old), OA Knee
- Keywords
- Isometric exercise, Home-based rehabilitation, Physical therapy, Non-pharmacological treatment, Pain management, Topical cannabidiol, Arnica montana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad del Valle de México, Campus CuernavacaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Participants were randomized to a 4×2 factorial design. Four topical treatment conditions (placebo, cannabidiol, arnica, cannabidiol plus arnica) were combined with two exercise conditions (home-based quadriceps isometric exercise vs no exercise), resulting in eight parallel intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Arm Title Placebo Topical + Isometric Exercise | Experimental | Drug: Placebo Topical Gel, Behavioral: Home-based Quadriceps Isometric ExerciseParticipants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days. |
| Placebo Topical Only | Experimental | Drug: Placebo Topical GelParticipants received placebo topical gel twice daily without exercise. |
| CBD Topical + Isometric Exercise | Experimental | Drug: Cannabidiol (CBD) Topical Gel, Behavioral: Home-based Quadriceps Isometric ExerciseParticipants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise. |
| CBD Topical Only | Experimental | Drug: Cannabidiol (CBD) Topical GelParticipants received cannabidiol topical formulation twice daily without exercise. |
| Arnica Topical + Isometric Exercise | Experimental | Drug: Arnica montana Topical Gel, Behavioral: Home-based Quadriceps Isometric ExerciseParticipants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise. |
| Arnica Topical Only | Experimental | Drug: Arnica montana Topical GelParticipants received Arnica montana topical formulation twice daily without exercise. |
| CBD + Arnica Topical + Exercise | Experimental | Behavioral: Home-based Quadriceps Isometric Exercise, Drug: CBD + Arnica Topical GelParticipants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise. |
| CBD + Arnica Topical Only | Experimental | Drug: CBD + Arnica Topical GelParticipants received combined cannabidiol and Arnica montana topical formulation twice daily without exercise. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Topical GelPlacebo topical formulation without active pharmacological ingredients, applied twice daily to the affected knee for 28 days. | Drug | Arm Title Placebo Topical + Isometric Exercise, Placebo Topical Only |
| Cannabidiol (CBD) Topical GelTopical cannabidiol formulation applied twice daily to the affected knee for 28 days. | Drug | CBD Topical + Isometric Exercise, CBD Topical Only |
| Arnica montana Topical GelTopical Arnica montana formulation applied twice daily to the affected knee for 28 days. | Drug | Arnica Topical + Isometric Exercise, Arnica Topical Only |
| Home-based Quadriceps Isometric ExerciseDaily home-based quadriceps isometric exercise protocol consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, performed for 28 days. | Behavioural | Arm Title Placebo Topical + Isometric Exercise, Arnica Topical + Isometric Exercise, CBD + Arnica Topical + Exercise, CBD Topical + Isometric Exercise |
| CBD + Arnica Topical Gelcombined cannabidiol and arnica formulation applied twice daily | Drug | CBD + Arnica Topical + Exercise, CBD + Arnica Topical Only |
Primary outcome
Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)
Time frame: 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.
4 secondary outcomes
Change from baseline in quadriceps isometric strength
Time frame: Baseline to Day 28
Change from baseline in body composition
Time frame: Baseline to Day 28
Exercise and topical treatment adherence
Time frame: Throughout the 28-day intervention
Adverse events
Time frame: Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional privacy policies and protection of patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol (CBD) Topical Gel, Arnica montana Topical Gel and Home-based Quadriceps Isometric Exercise in people with Older Adults (60 - 85 Years Old) and OA Knee, run by Universidad del Valle de México, Campus Cuernavaca at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS) (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.