Lumbar Disc HerniationNCT07870993
Nurse-Led Early Standing Exercise After Lumbar Fusion in Older Adults
A study testing Nurse-Led Early Standing Active Exercise Program and Routine Postoperative Rehabilitation in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This single-center, randomized controlled trial aimed to evaluate the effects of a nurse-led early standing active exercise program on postoperative functional recovery in older adults undergoing short-segment lumbar fusion. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
- What is being tested?
- Nurse-Led Early Standing Active Exercise Program and Routine Postoperative Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 10 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years.
- Diagnosis of a degenerative lumbar spinal disorder, including lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, or lumbar scoliosis.
- Scheduled for short-segment lumbar fusion surgery.
- Able to understand and participate in postoperative functional exercise.
- Provided written informed consent.
Who cannot join
- Concomitant surgical procedures.
- Neurological injuries or disorders that could interfere with postoperative exercise or functional assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 102218
About this study
Official title: A Randomized Controlled Trial of a Nurse-Led Early Standing Active Exercise Program in Older Adults Undergoing Short-Segment Lumbar Fusion
This single-center, randomized controlled trial aimed to evaluate the effects of a nurse-led early standing active exercise program on postoperative functional recovery in older adults undergoing short-segment lumbar fusion.
A total of 108 participants aged 65 years or older were randomly assigned in a 1:1 ratio to an intervention group or a control group. Both groups received routine postoperative rehabilitation. The intervention group additionally received a nurse-led standing exercise program initiated 16-24 hours after surgery, following a clinical safety assessment, and continued daily until hospital discharge.
The primary outcome was the six-minute walk distance, assessed before surgery and one day before discharge. Secondary outcomes included functional disability, pain intensity, and exercise adherence.
Read the detailed description
This single-center, parallel-group randomized controlled trial was conducted in the Department of Orthopedics at Xuanwu Hospital, Capital Medical University, Beijing, China.
Eligible participants were adults aged 65 years or older undergoing elective one- or two-level lumbar fusion for degenerative lumbar disorders. Participants were randomly assigned to either routine postoperative rehabilitation or routine rehabilitation supplemented with a nurse-led early standing active exercise program.
The additional exercise program comprised four standing exercises, initiated 16-24 hours after surgery following a clinical safety assessment and continued daily until discharge. Exercise intensity was adjusted according to individual tolerance, with nurses providing on-site supervision.
Outcome assessments were conducted before surgery and one day before discharge. Pain intensity was additionally assessed on the morning of postoperative day 1. The study used an open-label design, with outcome assessments primarily performed by nurses involved in delivering the intervention.
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis
- Being tested
- Nurse-Led Early Standing Active Exercise Program, Routine Postoperative Rehabilitation
- Keywords
- Lumbar Fusion, Older Adults, Early Mobilization, Standing Exercise, Postoperative Rehabilitation, Nurse-Led Intervention
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Early Standing Active Exercise ProgramBehavioural
A nurse-led early standing active exercise program provided in addition to routine postoperative rehabilitation. The program was initiated after surgery following a clinical safety assessment and was supervised by nurses during the postoperative hospital stay. Exercise was performed according to the study protocol and adjusted according to the participant's clinical condition and tolerance.
Routine Postoperative RehabilitationBehavioural
Routine postoperative rehabilitation provided according to the standard clinical care pathway during the postoperative hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Early Standing Exercise Group | Experimental | Participants received routine postoperative rehabilitation plus a nurse-led early standing active exercise program initiated after surgery following a clinical safety assessment. The program was supervised by nurses and continued during the postoperative hospital stay. Receives: Behavioral: Nurse-Led Early Standing Active Exercise Program; Behavioral: Routine Postoperative Rehabilitation |
| Routine Rehabilitation Group | Active comparator | Participants received routine postoperative rehabilitation according to the standard clinical care pathway during the postoperative hospital stay and did not receive the additional nurse-led early standing active exercise program. Receives: Behavioral: Routine Postoperative Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Distance (6MWD)
Functional walking capacity assessed using the 6-minute walk test. Participants walked as far as possible for 6 minutes in a quiet, level 30-m corridor under nurse supervision, and the total distance walked was recorded in meters.
Measured: Baseline, pre-surgery; 1 day before hospital discharge
Secondary outcomes (3)
Oswestry Disability Index (ODI)
Lumbar functional disability assessed using the modified Oswestry Disability Index. The instrument contains 10 items, each scored from 0 to 5, with a total score ranging from 0 to 50; higher scores indicate greater functional disability.
Measured: Baseline, pre-surgery; 1 day before hospital discharge
Pain Intensity (VAS)
Pain intensity assessed using a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, pre-surgery; postoperative day 1; 1 day before hospital discharge
Functional Exercise Adherence Scale for Orthopedic Patients (FEAS)
Functional exercise adherence assessed using the Functional Exercise Adherence Scale for Orthopedic Patients (FEAS), a 15-item self-report scale covering physical exercise adherence, psychological exercise adherence, and active learning adherence. Each item is rated on a 5-point Likert scale, yielding a total score of 15-75, with higher scores indicating better functional exercise adherence. The scale has demonstrated good internal consistency (Cronbach's α = 0.930).
Measured: 1 day before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start10 Jan 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either a nurse-led early standing active exercise group or a routine postoperative rehabilitation group and were followed in parallel until hospital discharge.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shibao Lu, Xuanwu Hospital, Beijing
- Investigators
- Jun Li, Bachelor, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870993
- Sponsor's protocol ID
- Xuanwu-Standing-2024
- Other IDs
- HLQN2022004, SZ202010025010, 19GLB081
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Nurse-Led Early Standing Active Exercise Program in Older Adults Undergoing Short-Segment Lumbar Fusion
- ClinicalTrials.gov ID
- NCT07870993
- Acronym / sponsor ID
- Xuanwu-Standing-2024
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis
- Keywords
- Lumbar Fusion, Older Adults, Early Mobilization, Standing Exercise, Postoperative Rehabilitation, Nurse-Led Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 13 Oct 2026 (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.
This single-center, randomized controlled trial aimed to evaluate the effects of a nurse-led early standing active exercise program on postoperative functional recovery in older adults undergoing short-segment lumbar fusion.
A total of 108 participants aged 65 years or older were randomly assigned in a 1:1 ratio to an intervention group or a control group. Both groups received routine postoperative rehabilitation. The intervention group additionally received a nurse-led standing exercise program initiated 16-24 hours after surgery, following a clinical safety assessment, and continued daily until hospital discharge.
The primary outcome was the six-minute walk distance, assessed before surgery and one day before discharge. Secondary outcomes included functional disability, pain intensity, and exercise adherence.
Detailed description
This single-center, parallel-group randomized controlled trial was conducted in the Department of Orthopedics at Xuanwu Hospital, Capital Medical University, Beijing, China.
Eligible participants were adults aged 65 years or older undergoing elective one- or two-level lumbar fusion for degenerative lumbar disorders. Participants were randomly assigned to either routine postoperative rehabilitation or routine rehabilitation supplemented with a nurse-led early standing active exercise program.
The additional exercise program comprised four standing exercises, initiated 16-24 hours after surgery following a clinical safety assessment and continued daily until discharge. Exercise intensity was adjusted according to individual tolerance, with nurses providing on-site supervision.
Outcome assessments were conducted before surgery and one day before discharge. Pain intensity was additionally assessed on the morning of postoperative day 1. The study used an open-label design, with outcome assessments primarily performed by nurses involved in delivering the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either a nurse-led early standing active exercise group or a routine postoperative rehabilitation group and were followed in parallel until hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Early Standing Exercise Group | Experimental | Behavioral: Nurse-Led Early Standing Active Exercise Program, Behavioral: Routine Postoperative RehabilitationParticipants received routine postoperative rehabilitation plus a nurse-led early standing active exercise program initiated after surgery following a clinical safety assessment. The program was supervised by nurses and continued during the postoperative hospital stay. |
| Routine Rehabilitation Group | Active comparator | Behavioral: Routine Postoperative RehabilitationParticipants received routine postoperative rehabilitation according to the standard clinical care pathway during the postoperative hospital stay and did not receive the additional nurse-led early standing active exercise program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥65 years.
- Diagnosis of a degenerative lumbar spinal disorder, including lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, or lumbar scoliosis.
- Scheduled for short-segment lumbar fusion surgery.
- Able to understand and participate in postoperative functional exercise.
- Provided written informed consent.
Key exclusion criteria (2 listed)
- Concomitant surgical procedures.
- Neurological injuries or disorders that could interfere with postoperative exercise or functional assessment.
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 Early Standing Active Exercise ProgramA nurse-led early standing active exercise program provided in addition to routine postoperative rehabilitation. The program was initiated after surgery following a clinical safety assessment and was supervised by nurses during the postoperative hospital stay. Exercise was performed according to the study protocol and adjusted according to the participant's clinical condition and tolerance. | Behavioural | Nurse-Led Early Standing Exercise Group |
| Routine Postoperative RehabilitationRoutine postoperative rehabilitation provided according to the standard clinical care pathway during the postoperative hospital stay. | Behavioural | Nurse-Led Early Standing Exercise Group, Routine Rehabilitation Group |
Primary outcome
6-Minute Walk Distance (6MWD)
Time frame: Baseline, pre-surgery; 1 day before hospital discharge
Functional walking capacity assessed using the 6-minute walk test. Participants walked as far as possible for 6 minutes in a quiet, level 30-m corridor under nurse supervision, and the total distance walked was recorded in meters.
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, pre-surgery; 1 day before hospital discharge
Pain Intensity (VAS)
Time frame: Baseline, pre-surgery; postoperative day 1; 1 day before hospital discharge
Functional Exercise Adherence Scale for Orthopedic Patients (FEAS)
Time frame: 1 day before hospital discharge
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 13 Oct 2026.
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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.
Jun Li, Bachelor principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Early Standing Active Exercise Program and Routine Postoperative Rehabilitation in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Xuanwu Hospital, Beijing at 1 site 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 5 inclusion and 2 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 13 Oct 2026. 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 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?
6-Minute Walk Distance (6MWD) (time frame: Baseline, pre-surgery; 1 day before hospital discharge). 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 13 Oct 2026.