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The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients

Primary Purpose

Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nurse-led interviewing
Brief group exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical University
  • The Second Affiliated Hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-led interviewing

Brief group exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Change from week 6 in physical activity levels measured by exercise log at week 12

Full Information

First Posted
February 27, 2014
Last Updated
February 27, 2014
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02075879
Brief Title
The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients
Official Title
The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief group exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led interviewing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brief group exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change from week 6 in physical activity levels measured by exercise log at week 12
Time Frame
Week 6 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan KY Chow, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Second Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
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.
Results Reference
derived
PubMed Identifier
25840898
Citation
Tao 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.
Results Reference
derived

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The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients

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