- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391189
Healthy Effects of Adapted Aikido in People With Grip Disfunction (AdAikido)
Study on the Health Effects of Adapted Physical Activity From Japanese Martial Arts-Aikido.
This study investigates the effects of an adapted aikido exercise program on
the health of adults with unilateral wrist and/or hand dysfunction. The un- derlying assumption is that regular practice of adapted aikido may improve
physical, psychological, and quality-of-life parameters in this population com- pared with a non-exercising control group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to assess the physical health benefits derived from an adapted aikido training program in people with unilateral reduction of wrist and hand functionality. Secondary objectives are to examine poten- tial benefits on mental health and to evaluate the influence of aikido practice on quality of life. Accordingly, the working hypothesis is that participation in the program will lead to significant improvements in physical, functional, and psychological variables compared with the control group.
A longitudinal, controlled, single-center study with repeated measures is proposed, including 20 adult participants, 10 in the intervention group and 10 in the control group, all without prior aikido experience and not practicing other martial arts during the study. The intervention consists of an adapted aikido program with two one-hour sessions per week over approximately four months, delivered by an experienced instructor, with systematic attendance recording to monitor adherence.
Primary outcomes include arm muscle mass, muscle strength (analytical dynamometry and handgrip test), active range of motion of the wrist, el- bow, and shoulder, body mass index, and cardiac function assessed via heart rate during exercise. Secondary outcomes are upper limb function (DASH), pain (VAS), sleep quality (PSQI and accelerometry), body awareness (BAQ), mindfulness (MAAS), anxiety (Hamilton Anxiety Scale), and positive and negative affect (PANAS).
Assessments will be conducted at three time points (baseline, mid-intervention, and post-intervention), combining clinical history, physical measurements, heart rate recordings, and psychological and quality-of-life questionnaires. Statistical analysis will include descriptive statistics, tests for normality and homoscedasticity, and repeated-measures ANCOVA with a significance level of 0.05 using R software, to determine the effect of adapted aikido on the different health indicators.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fernando Cánovas García
- Phone Number: 220 968278800
- Email: fcanovas@ucam.edu
Study Locations
-
-
Murcia
-
Murcia, Murcia, Spain, 30107
- Recruiting
- Catholic University of Murcia (UCAM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be of legal age.
- Have no prior knowledge of aikido.
- Not be practicing other martial arts at the time of inclusion in the study or during the adapted training program.
- Unilateral dysfunction of the hand and/or wrist that prevents or hinders tasks related to gripping (only for case group).
Exclusion Criteria:
- Presence of anatomical or functional alterations that could affect the performance of aikido techniques (other than those allowed for the study group).
- Intellectual disability and/or inability to understand the informed con- sent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Case group
Case group is formed by people with handgrip dysfunction
|
The aikido program has been adapted for optimal practice by people with handgrip dysfunction.
Several key components of the techniques have been modified to enable their performance by individuals with limited hand mo- bility.
|
|
Active Comparator: Control group
Control group is formed by healthy people
|
The aikido program has been adapted for optimal practice by people with handgrip dysfunction.
Several key components of the techniques have been modified to enable their performance by individuals with limited hand mo- bility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arm muscle mass
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Estimated from arm circumference and triceps skinfold measurements.
The instruments used will be an anthropometric tape and a skinfold caliper, respectively.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Muscle strength
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Analytical strength measurements will be taken for the main muscles responsible for each movement of the upper limb, as well as a handgrip test to assess overall hand grip strength.
The instruments used will be a Jamar dynamometer and a hand-held dynamometer.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Active joint mobility of the wrist, elbow, and shoulder
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
It will be measured using a digital inclinometer, an instrument that has shown lower measurement error than the universal goniome- ter, the standard tool for assessing joint range of motion.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Body Mass Index
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
It will be measured by bioelectrical impedance.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Cardiac function
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
It will be assessed by monitoring heart rate during exercise, using a chest-strap heart rate monitor.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper limb function
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, in its validated Spanish version.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Wrist and hand pain
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Measured using a Visual Analogue Scale
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Sleep quality
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Used as an indicator of quality of life and assessed with the Pittsburgh Sleep Quality Index (PSQI) and accelerometry.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Level of body awareness
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Measured with the Body Awareness Questionnaire
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Mindfulness or dispositional mindfulness values
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Measured using the Mindfulness Attention Awareness Scale and used as an indicator of psychological well-being.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Anxiety level
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Measured with the Hamilton Anxiety Scale, an anxiety scale with good psychometric properties that has been used in previous aikido studies.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
|
Positive and negative affect values
Time Frame: The evolution of the variable will be evaluated on days 60 and 120.
|
Measured using the Positive Affect Negative Affect Schedule, a test previously used in aikido interventions to assess their effect on the psychological state of practitioners.
|
The evolution of the variable will be evaluated on days 60 and 120.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UCAMCFE-00042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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