HemodialysisREHDPNCT06604221
Resistance Exercise in Hemodialysis Patients
A study testing Resistance exercise intervention and Routine care in people with Hemodialysis, run by Teng Zeng.
Trial summary
The goal of this clinical trial is to learn if an intradialytic resistance exercise intervention works to reduce the symptom burden in older maintenance hemodialysis patients. It will also learn about safety of the intradialytic resistance exercise intervention program. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Resistance exercise intervention and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2024to 3 Mar 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years and above Stable on dialysis for ≥3 months Able to walk independently, no physical disability, and muscle strength ≥ Grade III Capable of understanding and complying with the requirements of this study Voluntarily signed an informed consent form
Who cannot join
- Severe cardiovascular, cerebrovascular, respiratory, or neurological diseases, or other conditions that impair physical ability to exercise Serious infections, bleeding, trauma, or other conditions affecting physical status within the last 3 months Severe mental disorders or cognitive impairments Abnormal blood pressure (pre-dialysis systolic pressure ≥180mmHg, diastolic pressure ≥100mmHg) Hemoglobin (Hb) \< 90g/L, Albumin (Alb) ≤ 32g/L Participation in other exercise or pharmacological interventions in the past 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Resistance Exercise on Symptom Burden in Older Patients Undergoing Maintenance Hemodialysis
The goal of this clinical trial is to learn if an intradialytic resistance exercise intervention works to reduce the symptom burden in older maintenance hemodialysis patients. It will also learn about safety of the intradialytic resistance exercise intervention program. The main questions it aims to answer are:
- Does intradialytic resistance exercise effectively improve the number, frequency, and severity of symptoms in older patients?
- What adverse events may occur among older dialysis patients during exercise?
Read more
Researchers will compare older dialysis patients who undergo the intradialytic resistance exercise intervention with those receiving standard care to observe whether resistance exercise can improve symptom burden.
Participants will:
- Take an intradialytic resistance exercise intervention program developed through joint decision-making by rehabilitation experts, dialysis center physicians, nurses, and patients, conducted three times a week for 20 minutes each session, over a duration of three months.
- Visit the hospital a monthly for texts and examinations.
- Keep a diary of the types and frequency of adverse events during and after the exercise sessions.
- Conditions
- Hemodialysis
- Being tested
- Resistance exercise intervention, Routine care
- Keywords
- resistance exercise, hemodialysis, older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise interventionBehavioural
Also called intra dialysis resistance exercise
The exercise prescription, developed through expert meetings and integrated review summaries, consists of 27 items including: participant preparation, team preparation, exercise prescription FITT-VP, process monitoring, discontinuation criteria, termination criteria, recovery methods, outcome measures, and special considerations.
Routine careBehavioural
Also called Routine care for hemodialysis
1.Pre-dialysis Assessment:
- Vital Signs: Monitor blood pressure, heart rate, temperature.
- Access Care: Check the vascular access site for signs of infection and patency. 2.During Dialysis:
（1）Monitoring: Continuous vital signs and machine settings monitoring. （2）Fluid Management: Control fluid removal based on pre-dialysis weight. 3.Post-dialysis Care:
- Observation: Monitor for complications like hypotension, cramps, or bleeding.
- Weight Check: Weigh post-dialysis to verify fluid removal. 4.Education and Support:
（1）Diet: Educate on dietary restrictions (potassium, phosphorus, fluids). （2）Medications: Advise on medication adjustments. 5.Psychosocial Support:
（1）Provide emotional support and counseling.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Intervention Group | Experimental | Resistance exercise intervention plan, developed through expert meetings and integrated review summaries, consists of 27 items including: participant preparation, team preparation, exercise prescription FITT-VP, process monitoring, discontinuation criteria, termination criteria, recovery methods, outcome measures, and special considerations. Receives: Behavioral: Resistance exercise intervention; Behavioral: Routine care |
| control group | Active comparator | Routine care Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis Symptom Index
Kidney failure-related symptoms were assessed every month using the dialysis symptom index (DSI), a previously validated questionnaire Through this questionnaire, patients indicated the presence of 30 symptoms in the past month, resulting in a total sum score for symptom number ranging from 0 to 30. Additionally, for each symptom present, patients rated symptom burden on a five-point Likert scale, ranging from one for "not at all" to five for "very much" burdensome. Absent symptoms were assigned a score of zero, resulting in an overall symptom burden score ranging from zero to 150, with higher scores indicating larger burden.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
30 Seconds Sit To Stand Test
A chair with a hard seat whose floor-to-seat height was 48 cm was stabilized by placing it against a wall. After a researcher explained the requirements and precautions to the participant, the participant was asked to sit with his or her feet exactly flat on the ground and his or her upper limbs folded across his or her chest and then to stand up all the way and sit down again without using his or her arms. And the participant was asked to repeat as many of the sit-to-stand actions as possible in 30 seconds, and the maximum number completed was recorded.
Higher scores mean a better outcome.
Measured: From enrollment to the end of treatment at 12 weeks
Short Physical Performance Battery
(SPPB) which consists of 3 timed components: 1) a 4-meter usual pace walk, 2) a five-repetition chair stand without using one's arms, and 3) a progressive test of standing balance. Times from each component were scored from 0-4, with higher scores corresponding to better performance.
Measured: From enrollment to the end of treatment at 12 weeks
Number of participants with abnormal laboratory tests results
blood urea, blood creatinine, dialysis adequacy (Kt/V), hemoglobin, neutrophil-to-lymphocyte ratio, serum albumin, standardized protein catabolic rate, C-reactive protein, inflammatory factors
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024 (estimated)
- Primary completion3 Jan 2025 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teng Zeng
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital
- Responsible party
- Sponsor-investigator, Teng Zeng, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604221
- Sponsor's protocol ID
- 2024148
- Acronym
- REHDP
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Privacy Concerns: To protect participant privacy and confidentiality, given the sensitive nature of the data. 2. Research Integrity: To maintain the integrity of the research and prevent potential misuse of the data outside the specific study objectives. 3. Personal Decision: To retain control over data usage and ensure adherence to ethical standards and research protocols established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Resistance Exercise on Symptom Burden in Older Patients Undergoing Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT06604221
- Acronym / sponsor ID
- REHDP / 2024148
- Conditions
- Hemodialysis
- Keywords
- resistance exercise, hemodialysis, older people
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Teng ZengUniversity, hospital or other
- Collaborators
- Shengjing Hospital
- Study start
- 3 Oct 2024 (estimated)
- Primary completion
- 3 Jan 2025 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical trial is to learn if an intradialytic resistance exercise intervention works to reduce the symptom burden in older maintenance hemodialysis patients. It will also learn about safety of the intradialytic resistance exercise intervention program. The main questions it aims to answer are:
- Does intradialytic resistance exercise effectively improve the number, frequency, and severity of symptoms in older patients?
- What adverse events may occur among older dialysis patients during exercise?
Researchers will compare older dialysis patients who undergo the intradialytic resistance exercise intervention with those receiving standard care to observe whether resistance exercise can improve symptom burden.
Participants will:
- Take an intradialytic resistance exercise intervention program developed through joint decision-making by rehabilitation experts, dialysis center physicians, nurses, and patients, conducted three times a week for 20 minutes each session, over a duration of three months.
- Visit the hospital a monthly for texts and examinations.
- Keep a diary of the types and frequency of adverse events during and after the exercise sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Intervention Group | Experimental | Behavioral: Resistance exercise intervention, Behavioral: Routine careResistance exercise intervention plan, developed through expert meetings and integrated review summaries, consists of 27 items including: participant preparation, team preparation, exercise prescription FITT-VP, process monitoring, discontinuation criteria, termination criteria, recovery methods, outcome measures, and special considerations. |
| control group | Active comparator | Behavioral: Routine careRoutine care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60 years and above Stable on dialysis for ≥3 months Able to walk independently, no physical disability, and muscle strength ≥ Grade III Capable of understanding and complying with the requirements of this study Voluntarily signed an informed consent form
Key exclusion criteria (1 listed)
- Severe cardiovascular, cerebrovascular, respiratory, or neurological diseases, or other conditions that impair physical ability to exercise Serious infections, bleeding, trauma, or other conditions affecting physical status within the last 3 months Severe mental disorders or cognitive impairments Abnormal blood pressure (pre-dialysis systolic pressure ≥180mmHg, diastolic pressure ≥100mmHg) Hemoglobin (Hb) \< 90g/L, Albumin (Alb) ≤ 32g/L Participation in other exercise or pharmacological interventions in the past 6 months
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 |
|---|---|---|
| Resistance exercise interventionAlso: intra dialysis resistance exerciseThe exercise prescription, developed through expert meetings and integrated review summaries, consists of 27 items including: participant preparation, team preparation, exercise prescription FITT-VP, process monitoring, discontinuation criteria, termination criteria, recovery methods, outcome measures, and special considerations. | Behavioural | Resistance Exercise Intervention Group |
| Routine careAlso: Routine care for hemodialysis1.Pre-dialysis Assessment: 1. Vital Signs: Monitor blood pressure, heart rate, temperature. 2. Access Care: Check the vascular access site for signs of infection and patency. 2.During Dialysis: （1）Monitoring: Continuous vital signs and machine settings monitoring. （2）Fluid Management: Control fluid removal based on pre-dialysis weight. 3.Post-dialysis Care: 1. Observation: Monitor for complications like hypotension, cramps, or bleeding. 2. Weight Check: Weigh post-dialysis to verify fluid removal. 4.Education and Support: （1）Diet: Educate on dietary restrictions (potassium, phosphorus, fluids). （2）Medications: Advise on medication adjustments. 5.Psychosocial Support: （1）Provide emotional support and counseling. | Behavioural | Resistance Exercise Intervention Group, control group |
Primary outcome
Dialysis Symptom Index
Time frame: From enrollment to the end of treatment at 12 weeks
Kidney failure-related symptoms were assessed every month using the dialysis symptom index (DSI), a previously validated questionnaire Through this questionnaire, patients indicated the presence of 30 symptoms in the past month, resulting in a total sum score for symptom number ranging from 0 to 30. Additionally, for each symptom present, patients rated symptom burden on a five-point Likert scale, ranging from one for "not at all" to five for "very much" burdensome. Absent symptoms were assigned a score of zero, resulting in an overall symptom burden score ranging from zero to 150, with higher scores indicating larger burden.
3 secondary outcomes
30 Seconds Sit To Stand Test
Time frame: From enrollment to the end of treatment at 12 weeks
Short Physical Performance Battery
Time frame: From enrollment to the end of treatment at 12 weeks
Number of participants with abnormal laboratory tests results
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. 1. Privacy Concerns: To protect participant privacy and confidentiality, given the sensitive nature of the data. 2. Research Integrity: To maintain the integrity of the research and prevent potential misuse of the data outside the specific study objectives. 3. Personal Decision: To retain control over data usage and ensure adherence to ethical standards and research protocols established for this study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise intervention and Routine care in people with Hemodialysis, run by Teng Zeng.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeng Teng, Graduate Student (+86 13096390520, tengzeng412@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Symptom Index (time frame: From enrollment to the end of treatment at 12 weeks). 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 19 Sep 2024; AzTrials last refreshed its copy on 1 Nov 2026.