Kidney DiseaseNCT02075879
The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients
A study testing Nurse-led interviewing and Brief group exercise in people with Kidney Disease, run by The Hong Kong Polytechnic University at 2 sites in China.
Trial summary
The purpose of this study is to examine the effects of a nurse-led case management programme on home exercise training for haemodialysis patients. We hypothesised that: a. There is no significant difference in physical functioning between participants receiving the nurse-led home exercise training programme and those… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Nurse-led interviewing and Brief group exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2013to Dec 2013
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis for >3 months;
- Age > 18 years;
- Kt/V (dialysis adequacy) >1.2;
- Hemoglobin level > 8g/dl;
- Ambulatory without assistance ;
- Able to communicate in Chinese;
- Able to and willing to provide consent.
Who cannot join
- Unstable physical conditions or severe musculoskeletal diseases that might hinder exercise training;
- Severe hearing impairment;
- Diagnosed with mental diseases;
- Meeting or exceeding the exercise recommendation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
The Second Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
The purpose of this study is to examine the effects of a nurse-led case management programme on home exercise training for haemodialysis patients. We hypothesised that: a. There is no significant difference in physical functioning between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. b. There is no difference in depression between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. c. There is no difference in quality of life and health perception between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. d. There is no difference in physical activity levels between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. e. There is no difference in perceived benefits and barriers of exercise between participants receiving the nurse-led home exercise training programme and those receiving the comparison care.
The study was a randomized controlled trial conducted in two haemodialysis units of two tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study group or comparison group. Participants in both groups received the in-center exercise training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was focused on flexibility and strengthening exercise. Patients were encouraged to have cardiovascular exercises at home which will improve their cardiovascular conditions and endurance. The list of cardiovascular exercise included brisk walking, bicycling, jogging. Participants in the study group were instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the study group patients weekly for six weeks and biweekly for another six weeks. Participants in the comparison group only participated in the in-center exercise training. The comparison group patients received usual care from the nurse without the interviews and mutual goals developed.
Read the detailed description
The duration of interventions was 12 weeks. In-center exercise training sessions were available for all participants once a week for 6 weeks. Each session lasted about 20 minutes. Participants were instructed to perform flexibility and strength exercise in centres prior to the haemodialysis session. The researcher performed exercises with the participants and emphasised the importance of self-monitoring during the sessions. Symptoms (such as chest pain, dyspnea, dizziness, and leg cramps) and vital signs (blood pressure, heart rate, and pulse) were checked before exercise and monitored during the entire exercise session. Participants were instructed to self-monitor exercise intensity. The exercise programme was pause immediately if the patient was feeling short of breath, chest pain or pressure, irregular heartbeats, leg cramps, dizziness or lightheadedness, blurring of vision, or any discomfort.
Intervention group During the study period, participants in the intervention group received additional face-to-face interviews conducted by the designated case managers every week for six weeks and biweekly for another six weeks. During interviews, patients were instructed to start aerobic exercise, such as walking, jogging, cycling, or brisk walking at home at low duration and gradually progress to a maximum of 30 minutes daily per week. Apart from aerobic exercise, patients were recommended to perform strength exercises twice a week and flexibility exercises for every day. The key elements of the interview included: 1) assessment of patients' knowledge and exercise behaviour; examining patients' attitudes and feelings about being physical activity; 2) explore patients' barriers to exercise and perceived benefits; 3) patient education on the benefits of exercise if needed; 4) development of mutual goals in an exercise plan; 5) explain the purpose of a recording exercise log and instruction in correct way to keep an exercise diary; 6) discuss the available supports and resources that could motivate patients to initiate and maintain exercise, e.g., centre-based exercise programme, support from family members, health care providers, peer patients, and so forth.
In the follow-up interviews, case managers reviewed the exercise log with participants, discussed unpleasant experiences related to exercise, exercise progress, and provided encouragement. According to the progress participants made, the exercise goals and plan were renewed or revised. Referrals were made as needed.
Comparison group Participants in the comparison group were advised to participate in the in-centre exercise training programme which was available before haemodialysis sessions once a week for different shifts of patients. The training session lasted about 20 minutes and only flexibility and strength training were provided. During the training sessions, patients were advised to increase their daily activity levels.
- Conditions
- Kidney Disease
- Being tested
- Nurse-led interviewing, Brief group exercise
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led interviewingBehavioural
Participants in experimental arm received regular face-to-face interviews during dialysis sessions conducted by the designated case managers every week for 6 weeks and biweekly for another 6 weeks.
Brief group exerciseOther
Participants in this arm only participated in the brief in-center exercise training. They received usual care from the nurse without the interviews and mutual goals developed.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led interviewing | Experimental | Participants in experimental arm received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. They were additionally instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the patients weekly for six weeks and biweekly for another six weeks. Receives: Behavioral: Nurse-led interviewing |
| Brief group exercise | Active comparator | Participants received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was conducted by the researcher with a group of four-to six participants focusing on flexibility and strengthening exercise only. Receives: Other: Brief group exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in walking speed on the 10-meter walking test at week 6 and change from baseline in walking speed on 10-meter walking test at week 12
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (6)
Change from baseline in time in completing the 10-repetition sit-to-stand test (10-STS) at week 6, and change from baseline in time in completing 10-STS at week 12
Measured: Baseline, Week 6, and Week 12
Change from baseline in perceived exercise benefits and barriers on the Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS) at week 6 and change from baseline in the DPEBBS score at week 12
Measured: Baseline, Week 6, and Week 12
Change from baseline in health-related quality of life on the Kidney Disease Quality of Life Questionnaire (KDQOL-36) at week 6, and change from baseline in KDQOL-36 score at week 12
Measured: Baseline, Week 6, and Week 12
Change from baseline in depressive symptoms on the Beck Depression Inventory (BDI) at week 6, and change from baseline in BDI score at week 12
Measured: Baseline, Week 6, and Week 12
Change from baseline in self-perceived health in the first item in the Kidney Disease Quality of Life Questionnaire at week 6, and change from baseline in self-perceived health score at week 12
Measured: Baseline, Week 6, and Week 12
Change from week 6 in physical activity levels measured by exercise log at week 12
Measured: Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Ka Yee Chow, The Hong Kong Polytechnic University
- Investigators
- Susan KY Chow, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075879
- Sponsor's protocol ID
- HSEARS20121105002
- Status last verified
- Feb 2014
- First submitted
- 27 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639Tao X, Chow SK, Wong FK. A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial. Int J Nurs Stud. 2015 Jun;52(6):1029-41. doi: 10.1016/j.ijnurstu.2015.03.013. Epub 2015 Mar 26.
PubMed 25840898
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT02075879
- Acronym / sponsor ID
- HSEARS20121105002
- Conditions
- Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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 purpose of this study is to examine the effects of a nurse-led case management programme on home exercise training for haemodialysis patients. We hypothesised that: a. There is no significant difference in physical functioning between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. b. There is no difference in depression between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. c. There is no difference in quality of life and health perception between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. d. There is no difference in physical activity levels between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. e. There is no difference in perceived benefits and barriers of exercise between participants receiving the nurse-led home exercise training programme and those receiving the comparison care.
The study was a randomized controlled trial conducted in two haemodialysis units of two tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study group or comparison group. Participants in both groups received the in-center exercise training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was focused on flexibility and strengthening exercise. Patients were encouraged to have cardiovascular exercises at home which will improve their cardiovascular conditions and endurance. The list of cardiovascular exercise included brisk walking, bicycling, jogging. Participants in the study group were instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the study group patients weekly for six weeks and biweekly for another six weeks. Participants in the comparison group only participated in the in-center exercise training. The comparison group patients received usual care from the nurse without the interviews and mutual goals developed.
Detailed description
The duration of interventions was 12 weeks. In-center exercise training sessions were available for all participants once a week for 6 weeks. Each session lasted about 20 minutes. Participants were instructed to perform flexibility and strength exercise in centres prior to the haemodialysis session. The researcher performed exercises with the participants and emphasised the importance of self-monitoring during the sessions. Symptoms (such as chest pain, dyspnea, dizziness, and leg cramps) and vital signs (blood pressure, heart rate, and pulse) were checked before exercise and monitored during the entire exercise session. Participants were instructed to self-monitor exercise intensity. The exercise programme was pause immediately if the patient was feeling short of breath, chest pain or pressure, irregular heartbeats, leg cramps, dizziness or lightheadedness, blurring of vision, or any discomfort.
Intervention group During the study period, participants in the intervention group received additional face-to-face interviews conducted by the designated case managers every week for six weeks and biweekly for another six weeks. During interviews, patients were instructed to start aerobic exercise, such as walking, jogging, cycling, or brisk walking at home at low duration and gradually progress to a maximum of 30 minutes daily per week. Apart from aerobic exercise, patients were recommended to perform strength exercises twice a week and flexibility exercises for every day. The key elements of the interview included: 1) assessment of patients' knowledge and exercise behaviour; examining patients' attitudes and feelings about being physical activity; 2) explore patients' barriers to exercise and perceived benefits; 3) patient education on the benefits of exercise if needed; 4) development of mutual goals in an exercise plan; 5) explain the purpose of a recording exercise log and instruction in correct way to keep an exercise diary; 6) discuss the available supports and resources that could motivate patients to initiate and maintain exercise, e.g., centre-based exercise programme, support from family members, health care providers, peer patients, and so forth.
In the follow-up interviews, case managers reviewed the exercise log with participants, discussed unpleasant experiences related to exercise, exercise progress, and provided encouragement. According to the progress participants made, the exercise goals and plan were renewed or revised. Referrals were made as needed.
Comparison group Participants in the comparison group were advised to participate in the in-centre exercise training programme which was available before haemodialysis sessions once a week for different shifts of patients. The training session lasted about 20 minutes and only flexibility and strength training were provided. During the training sessions, patients were advised to increase their daily activity levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led interviewing | Experimental | Behavioral: Nurse-led interviewingParticipants in experimental arm received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. They were additionally instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the patients weekly for six weeks and biweekly for another six weeks. |
| Brief group exercise | Active comparator | Other: Brief group exerciseParticipants received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was conducted by the researcher with a group of four-to six participants focusing on flexibility and strengthening exercise only. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Dialysis for >3 months;
- Age > 18 years;
- Kt/V (dialysis adequacy) >1.2;
- Hemoglobin level > 8g/dl;
- Ambulatory without assistance ;
Key exclusion criteria (4 listed)
- Unstable physical conditions or severe musculoskeletal diseases that might hinder exercise training;
- Severe hearing impairment;
- Diagnosed with mental diseases;
- Meeting or exceeding the exercise recommendation.
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 |
|---|---|---|
| Nurse-led interviewingParticipants in experimental arm received regular face-to-face interviews during dialysis sessions conducted by the designated case managers every week for 6 weeks and biweekly for another 6 weeks. | Behavioural | Nurse-led interviewing |
| Brief group exerciseParticipants in this arm only participated in the brief in-center exercise training. They received usual care from the nurse without the interviews and mutual goals developed. | Other | Brief group exercise |
Primary outcome
Change from baseline in walking speed on the 10-meter walking test at week 6 and change from baseline in walking speed on 10-meter walking test at week 12
Time frame: Baseline, Week 6, and Week 12
6 secondary outcomes
Change from baseline in time in completing the 10-repetition sit-to-stand test (10-STS) at week 6, and change from baseline in time in completing 10-STS at week 12
Time frame: Baseline, Week 6, and Week 12
Change from baseline in perceived exercise benefits and barriers on the Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS) at week 6 and change from baseline in the DPEBBS score at week 12
Time frame: Baseline, Week 6, and Week 12
Change from baseline in health-related quality of life on the Kidney Disease Quality of Life Questionnaire (KDQOL-36) at week 6, and change from baseline in KDQOL-36 score at week 12
Time frame: Baseline, Week 6, and Week 12
Change from baseline in depressive symptoms on the Beck Depression Inventory (BDI) at week 6, and change from baseline in BDI score at week 12
Time frame: Baseline, Week 6, and Week 12
Change from baseline in self-perceived health in the first item in the Kidney Disease Quality of Life Questionnaire at week 6, and change from baseline in self-perceived health score at week 12
Time frame: Baseline, Week 6, and Week 12
Change from week 6 in physical activity levels measured by exercise log at week 12
Time frame: Week 6 and Week 12
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 2014.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 25840898Tao X, Chow SK, Wong FK. A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial. Int J Nurs Stud. 2015 Jun;52(6):1029-41. doi: 10.1016/j.ijnurstu.2015.03.013. Epub 2015 Mar 26.
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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.
Susan KY Chow, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led interviewing and Brief group exercise in people with Kidney Disease, run by The Hong Kong Polytechnic University at 2 sites in China.
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 7 inclusion and 4 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 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 walking speed on the 10-meter walking test at week 6 and change from baseline in walking speed on 10-meter walking test at week 12 (time frame: Baseline, Week 6, and Week 12). 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 NCT02075879, which also lists 2 linked publications.
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 2014.