RehabilitationNCT03030092
Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
A study testing Maximal Strength Training in people with Rehabilitation, run by Molde University College.
Trial summary
One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Maximal Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2019
- 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 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age over 65, hip fracture surgery
Who cannot join
- COPD, Heart failure, Dementia
About this study
One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried out. Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.
- Conditions
- Rehabilitation
- Being tested
- Maximal Strength Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal Strength TrainingOther
leg pres and abduction exercises
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Today's standard care |
| Intervention group | Experimental | Maximal Strength Training Receives: Other: Maximal Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
1RM leg press, and hip abduction
Measured: 8 weeks
Balance
unipedal stance test
Measured: 8 weeks
Bone Density
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2019
- Study completionJun 2019
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 RehabilitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030092
- Sponsor's protocol ID
- Berg10069
- Status last verified
- Jul 2020
- First submitted
- 18 Jan 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134Berg OK, Stutzer JM, Hoff J, Wang E. Early Maximal Strength Training Improves Leg Strength and Postural Stability in Elderly Following Hip Fracture Surgery. Geriatr Orthop Surg Rehabil. 2021 Apr 30;12:21514593211015103. doi: 10.1177/21514593211015103. eCollection 2021.
PubMed 34017617
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
- ClinicalTrials.gov ID
- NCT03030092
- Acronym / sponsor ID
- Berg10069
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 24 Jan 2017 (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.
One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried out. Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Today's standard care |
| Intervention group | Experimental | Other: Maximal Strength TrainingMaximal Strength Training |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age over 65, hip fracture surgery
Key exclusion criteria (1 listed)
- COPD, Heart failure, Dementia
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 |
|---|---|---|
| Maximal Strength Trainingleg pres and abduction exercises | Other | Intervention group |
Primary outcome
Muscle strength
Time frame: 8 weeks
1RM leg press, and hip abduction
Balance
Time frame: 8 weeks
unipedal stance test
Bone Density
Time frame: 8 weeks
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 7 Jul 2020.
- Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
- Derived from this study: PubMed 34017617Berg OK, Stutzer JM, Hoff J, Wang E. Early Maximal Strength Training Improves Leg Strength and Postural Stability in Elderly Following Hip Fracture Surgery. Geriatr Orthop Surg Rehabil. 2021 Apr 30;12:21514593211015103. doi: 10.1177/21514593211015103. eCollection 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal Strength Training in people with Rehabilitation, run by Molde University College.
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: finished, as of the sponsor's last update on 7 Jul 2020. 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?
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?
Muscle strength (time frame: 8 weeks). 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 NCT03030092, 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 7 Jul 2020.