Muscle WeaknessNCT05493046
Interactive Hand Exercise Game on Grip Strength and Vascular Maturation
A study testing Interactive Hand Exercise Game and Soft ball exercise ( routine care) in people with Muscle Weakness and Angiogenesis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Muscle Weakness, Angiogenesis
- What is being tested?
- Interactive Hand Exercise Game and Soft ball exercise ( routine care)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2022to 20 Nov 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic renal failure stage 4 to 5 (before dialysis) and stage 5 (patients who have started hemodialysis).
- Newly established surgical patients with autologous arteriovenous fistula.
- Aged between 20 and 70 years old.
- Having clear consciousness and being able to communicate in Chinese.
Who cannot join
- Previous dysfunction of an autologous arteriovenous fistula in the same arm.
- Injury to the fistula extremity.
- Neuromusculoskeletal abnormalities.
- Upper extremity arthritis.
- Peripheral neuropathy.
- Peripheral arterial dysfunction.
- Venous disease.
- Rheumatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Interactive Hand Exercise Game on Grip Strength and Vascular Maturation in Patients Undergoing Arteriovenous Fistula Surgery: A Randomized Controlled Trial
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy.
The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.
Read the detailed description
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy.
The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with a postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.
The patients will be assigned to the experimental group and the control group by a simple random method, with 15 patients in each group. The experimental group was guided by the interactive hand exercise game program, while the control group received conventional softball exercise. Two groups of patients will start to perform hand exercises on the first day after returning home. The two groups need to perform 30 minutes each time, twice a day (once in the morning and once in the afternoon), for a total of two months. To assess the study outcomes (i.e., hand grip strength and maturation) will use self-structured questionnaires, Noblus ultrasonic machine and Jamar hydraulic grip. The measurement time points are the one week before, the first week, the fourth weeks and the eighth weeks after the autologous arteriovenous fistula operation.
- Conditions
- Muscle Weakness, Angiogenesis
- Being tested
- Interactive Hand Exercise Game, Soft ball exercise ( routine care)
- Keywords
- Hand-grip Strength, Hemodialysis
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Hand Exercise GameBehavioural
Interactive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery
Soft ball exercise ( routine care)Behavioural
Soft ball exercise ( routine care)
| Study group | Role | What they receive |
|---|---|---|
| Interactive Hand Exercise Game | Experimental | Participants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months. Receives: Behavioral: Interactive Hand Exercise Game |
| Soft ball exercise ( routine care) | Active comparator | Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months. Receives: Behavioral: Soft ball exercise ( routine care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vein diameter
This will be measured by using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a cross-sectional luminal diameter of the draining vein >6 mm.
Measured: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery
Changes in the depth of the fistula from the epidermis
The depth of the fistula from the epidermis is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula should be <0.6 cm from the epidermis.
Measured: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Changes in brachial artery blood flow rate
The flow rate is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a flow velocity in the artery >600 ml/min.
Measured: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Secondary outcomes (1)
Changes in grip strength
The grip strength is measured using the Jamar Grip. The size is set to 2 for women, 1 for those with smaller hands, and 3 for men.
Measured: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start10 Aug 2022
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
- Investigators
- Chiu Hsiao-Yean, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493046
- Sponsor's protocol ID
- 22MMHIS083e
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo YC, Han PH, Chen YY, Wu PC, Wu IW, Fan YC, Chiu HY. Effects of an Interactive Handgrip Game on Vascular Maturation and Grip Strength in Patients Undergoing Arteriovenous Fistula Surgery: A Feasibility Randomized Controlled Trial. Hemodial Int. 2026 Apr;30(2):343-350. doi: 10.1111/hdi.70045. Epub 2026 Jan 1.
PubMed 41479242
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Hand Exercise Game on Grip Strength and Vascular Maturation in Patients Undergoing Arteriovenous Fistula Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05493046
- Acronym / sponsor ID
- 22MMHIS083e
- Conditions
- Muscle Weakness, Angiogenesis
- Keywords
- Hand-grip Strength, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 9 Aug 2022 (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.
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy.
The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.
Detailed description
Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy.
The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with a postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.
The patients will be assigned to the experimental group and the control group by a simple random method, with 15 patients in each group. The experimental group was guided by the interactive hand exercise game program, while the control group received conventional softball exercise. Two groups of patients will start to perform hand exercises on the first day after returning home. The two groups need to perform 30 minutes each time, twice a day (once in the morning and once in the afternoon), for a total of two months. To assess the study outcomes (i.e., hand grip strength and maturation) will use self-structured questionnaires, Noblus ultrasonic machine and Jamar hydraulic grip. The measurement time points are the one week before, the first week, the fourth weeks and the eighth weeks after the autologous arteriovenous fistula operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Hand Exercise Game | Experimental | Behavioral: Interactive Hand Exercise GameParticipants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months. |
| Soft ball exercise ( routine care) | Active comparator | Behavioral: Soft ball exercise ( routine care)Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of chronic renal failure stage 4 to 5 (before dialysis) and stage 5 (patients who have started hemodialysis).
- Newly established surgical patients with autologous arteriovenous fistula.
- Aged between 20 and 70 years old.
- Having clear consciousness and being able to communicate in Chinese.
Key exclusion criteria (8 listed)
- Previous dysfunction of an autologous arteriovenous fistula in the same arm.
- Injury to the fistula extremity.
- Neuromusculoskeletal abnormalities.
- Upper extremity arthritis.
- Peripheral neuropathy.
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 |
|---|---|---|
| Interactive Hand Exercise GameInteractive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery | Behavioural | Interactive Hand Exercise Game |
| Soft ball exercise ( routine care)Soft ball exercise ( routine care) | Behavioural | Soft ball exercise ( routine care) |
Primary outcome
Changes in vein diameter
Time frame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery
This will be measured by using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a cross-sectional luminal diameter of the draining vein >6 mm.
Changes in the depth of the fistula from the epidermis
Time frame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
The depth of the fistula from the epidermis is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula should be <0.6 cm from the epidermis.
Changes in brachial artery blood flow rate
Time frame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
The flow rate is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a flow velocity in the artery >600 ml/min.
1 secondary outcome
Changes in grip strength
Time frame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
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 15 Aug 2025.
- Derived from this study: PubMed 41479242Luo YC, Han PH, Chen YY, Wu PC, Wu IW, Fan YC, Chiu HY. Effects of an Interactive Handgrip Game on Vascular Maturation and Grip Strength in Patients Undergoing Arteriovenous Fistula Surgery: A Feasibility Randomized Controlled Trial. Hemodial Int. 2026 Apr;30(2):343-350. doi: 10.1111/hdi.70045. Epub 2026 Jan 1.
- Individual participant dataSharing planned: No
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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.
Chiu Hsiao-Yean, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Hand Exercise Game and Soft ball exercise ( routine care) in people with Muscle Weakness and Angiogenesis, run by Taipei Medical University at 1 site in Taiwan.
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 4 inclusion and 8 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 15 Aug 2025. 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 Taiwan. 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?
Changes in vein diameter (time frame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05493046, which also lists 1 linked publication.
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 15 Aug 2025.