Hip FracturesNCT05840315
Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture
A study testing Basic intervention and nutritional intervention, Sit-to-stand and Leg press in people with Hip Fractures and Sarcopenia, run by Horsholm Municipality at 1 site in Denmark.
Trial summary
The objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures, Sarcopenia, Fall Injury
- What is being tested?
- Basic intervention and nutritional intervention, Sit-to-stand and Leg press
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2023to 6 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Moderate to severe dementia
- Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
- Cancer
- Alcohol intake >21/14 units a week for men/women.
- Patients not allowed full weight bearing on the fractured leg
- Patients with 2 Hansson pins or similar procedure for cervical femoral fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture. A Non-randomized Pilot Trial
The objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program.
Feasibility criteria is defined as: 1) hip fracture-related pain might increase during the exercise programme, but not persistent after each session. 2) adherence to the program must be 75% or more. 3) Less than 20% drop-outs due to pain and/or discomfort during training.
Read the detailed description
Background and rationale:
Hip fractures are associated with decrease in muscle strength, Rehabilitation after hip fractures typically include types of resistance training, functional training and cardiovascular training Factors affecting the functional prognosis after hip fracture surgery are multiple, and patients are at risk of decreased physical function new injurious falls and fractures and increased need of supportive care.
Earlier research has shown that daily on weekdays, progressive knee-extension strength training (three sets with a 10RM load) is a feasible and potentially effective treatment for increasing muscle strength in patients with hip fractures when commenced few days after surgery.
Extended physical therapy including strength training implemented about 6 weeks or later after hip fracture surgery seem to promote recovery of physical function.
The goal of rehabilitation is to reach the highest degree of autonomy as possible, which in sarcopenic older adults requires increasing the muscle strength in the lower extremities. Higher volume resistance training has been associated with increased muscle mass and strength in both young and older populations Resistance training for elderly patients is usually done to failure to ensure adequate volume for muscle hypertrophy and strength increases.
In comparison, Sit-to-stand chair exercises has earlier been executed as progressive training and shows promising results as to increasing ability to rise from a lower chair In stroke patients. Sit-to-stand exercise has been shown to be a good whole body exercise and with effects of the exercises ranging from increased leg strength to association with lower degree of dysphagia in stroke patients, when done in addition to the convalescence rehabilitation program.
To the researchers knowledge there exist no other trials testing systematic use of very high training volume of sit-to-stand exercises in rehabilitation of older patients with hip fractures.
This trial searches to combine training with high volume of sit-to-stand exercises with training to volitional failure on leg press and hip abductions to employ combinations of heavy, progressive resistance training and very high volume of total training (29 sets per week) Objectives The objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program.
Feasibility criteria is defined as: 1) hip fracture-related pain might increase during the exercise programme, but not persistent after each session. 2) adherence to the program must be 75% or more. 3) Less than 20% drop-outs due to pain and/or discomfort during training.
- Conditions
- Hip Fractures, Sarcopenia, Fall Injury
- Being tested
- Basic intervention and nutritional intervention, Sit-to-stand, Leg press, Hip abduction
- Keywords
- physical therapy, resistance training
- Medical subject headings
- Hip Fractures, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic intervention and nutritional interventionDietary supplement
Also called Nutritional intervention
The training plan is divided into 3 parts with different sub-components. There will be ongoing enrollment until 10 participants have been recruited, after which the next sub-trial will start recruitment. The intervention from the respective sub-trials is described in the individual study phases.
Participants attend one-hour exercise sessions, 2 times/week for 8 weeks, in groups of 4-7 patients, supervised by 2-3 physio therapists.
After completion of the physical intervention all participants are given a nutritional supplement, being a 200ml cocoa(Chokolate milk), containing 7 grams of protein, 24grams of carbohydrates, 5 grams of fat and in total 166 kilocalories. If any participant has lactose intolerance or diabetes, they are advised to bring an egg and a piece of rye bread to secure an equal amount of protein and calories.
Sit-to-standProcedure or surgery
Also called Resistance training
First subtrial (participants 1-10):
Sit-to-stand-to-sit training: Participants will be instructed to do as many sit-to-stand repetitions as possible without using their arms in a 30 second window, followed by a 30 second rest. This sequence is repeated for a total of 10 sets (a total of 10 minutes). Standard seat height of chair is 46 cm.
Progression/regression: If a participant is unable to do at least 6 repetitions on the first sit-to-stand test, they are allowed to sit on a 6cm airex pillow while performing the exercise. When a single set of 12 chair rises are attained or total amount of repetitions reach 100 in 10 sets on an airex, the participant progresses to sitting on a 6-0,5cm wedge pillow, and again when the participant attains 12 rises, he/she progress to rising from the standard chair height.
Leg pressProcedure or surgery
Also called Resistance training
Second subtrial (participants 11-20):
In addition to the above intervention, progressive strength training is performed on a leg press, consisting of 3 sets of 8-12RM. Participants are instructed to do as many repetitions as possible, and the weight is increased if either 12 repetitions are performed on three consecutive sets or a single set or more than 14 repetitions are completed. If fewer than 6 repetitions are performed, the weight is reduced . There is a minimum of one minute break between each set of training on the leg press.
Hip abductionProcedure or surgery
Also called Resistance training
Third subtrial (participants 21-30):
In addition to interventions described in sub-trial 1, Third subtrial will perform progressive strength training for the gluteal muscles is carried out in form of hip abduction, using rubber bands, consisting of 3 sets of 8-12RM using the same procedure as above mentioned for the leg press.
Hip abduction will be performed from a standing position with a straight arm length from a wall, supporting the wall. The participant will be instructed to abduct the hip facing the wall until the foot is in contact with the wall, and then back until it touches the standing leg.
Progression will be placing a rubber band just proximal to the knee with resistances being: yellow= light, red= moderate, blue= heavy.
further progression will be placing the rubber band around the ankles using the same progression as above.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | First subtrial (participants 1-10):
Sit-to-stand-to-sit training Receives: Dietary Supplement: Basic intervention and nutritional intervention; Procedure: Sit-to-stand |
| Phase 2 | Experimental | Second subtrial (participants 11-20):
Sit-to-stand and leg press training. Receives: Dietary Supplement: Basic intervention and nutritional intervention; Procedure: Sit-to-stand; Procedure: Leg press |
| Phase 3 | Experimental | Third subtrial (participants 21-30):
Sit-to-stand and hip abduction training. Receives: Dietary Supplement: Basic intervention and nutritional intervention; Procedure: Sit-to-stand; Procedure: Hip abduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the interventions; Adherence
Feasibility is evaluated based on adherence to the program. Adherence to the program must be 75% or more, and drop outs due to pain or discomfort during training should be no more than 20%.
Measured: Measured during the 8 week intervention
Tolerability of the interventions; Hip fracture related pain
Hip fracture-related pain during exercise, and dropouts. Hip fracture-related pain should not increase to more than a maximum of 3 VRS points (severe pain) during exercise and reduced thereafter, Patient rating pain on a verbal rating scale of 0-4 0: no pain, 1: slight pain, 2: Moderate pain, 3: severe pain and 4: Unbearable pain.
Measured: Measured during the 8 week intervention
Secondary outcomes (9)
Sit-to-stand- test
Change in the number of times the patient comes to full standing position in 30 seconds from a chair with a seat height of 44-47cm. The Sit to Stand test provides a measurement of a person's lower body (particularly quadriceps) strength(18). Hip-pain will be assessed before and after (describing the maximum pain during testing) testing with the VRS (17).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Change in 10m walk test, using regular walk speed and standing start.
The time it takes the patient to walk 10 meters with a standing start, using walking aid if needed (19). The 10m. walk test gives an indication of a person's ability to walk and is recommended in the sarcopenia screening algorithm (20).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Change in Handgrip strength
The maximum grip force a person can apply to a handheld dynamometer, defined as the highest of three maximum efforts (up to five) with the dominant hand. Handgrip strength is associated with total upper body strength and is recommended in the sarcopenia screening algorithm(18,20)
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
SARC-F questionnaire
The Sarc-F is a 5-item questionnaire subjectively assessing strength, ability to walk, rise from a chair, walking on stairs and how often a person falls. Sarc-F is associated with the prevalence of sarcopenia and is the first test in the sarcopenia screening algorithm (20).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Prevalence and severity of sarcopenia
Sarcopenia is defined according to the European guidelines EWSGOP2 (20), based on low muscle strength (measured as Handgrip strength or STS test), Low muscle mass (measured with bioimpedance) and low muscle function (measured with 10m walk test or other performance tests )(20).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
New mobility score
New Mobility Score assesses walking function; indoor, outdoors and during shopping. 0-3 points are given for each function, resulting in a score ranging from 0-9 points. A change of 1 point is considered as clinically relevant change. New mobility score is a strong predictor of mortality and other outcomes after hip fracture (21,22).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall)
Falls Efficacy Scale-International
Falls Efficacy Scale-International is a measure of "concerns about falling" intended to be used in an adult and elderly population. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling) (23).
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Quality of life by EQ5D-5L
Assessment of quality of life using the EQ-5D-5L. EQ-5D is a non-disease-specific (generic) instrument developed to assess health-related quality of life. Rating instrument based on self-assessment of one's own condition. The EQ-5D is a widely used generic health-related quality of life instrument that has been used to describe population health and health outcomes in clinical trials and health economic evaluations
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Quality of life by EQ-VAS
Assessment of quality of life using the EQ-VAS. EQ-5D is a non-disease-specific (generic) instrument developed to assess health-related quality of life. Rating instrument based on self-assessment of one's own condition. The EQ-5D is a widely used generic health-related quality of life instrument that has been used to describe population health and health outcomes in clinical trials and health economic evaluations
Measured: Baseline(within the first week before starting the intervention) and immediately post intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start21 Mar 2023
- Primary completion1 Sep 2025
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Three stages of single arm non-randomized feasibility trial set-up, testing an interventions feasibility, combined with the usual rehabilitation program.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsholm Municipality
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Grundt Hansen, Horsholm Municipality
- Investigators
- Niklas Grundt Hansen, Msc. PT, Principal investigator, Research therapist, Hørsholm municipality, capital regionMorten Ta Kristensen, Professor, Study director, Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg hospitals, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840315
- Sponsor's protocol ID
- RSS protokol Hoftefrak
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Feasibility of progressive strength training implemented in the acute ward after hip fracture surgery. PLoS One. 2014 Apr 3;9(4):e93332. doi: 10.1371/journal.pone.0093332. eCollection 2014.
PubMed 24699276Kristensen MT, Bandholm T, Bencke J, Ekdahl C, Kehlet H. Knee-extension strength, postural control and function are related to fracture type and thigh edema in patients with hip fracture. Clin Biomech (Bristol). 2009 Feb;24(2):218-24. doi: 10.1016/j.clinbiomech.2008.10.003. Epub 2008 Dec 16.
PubMed 19091449Overgaard J, Kristensen MT. Feasibility of progressive strength training shortly after hip fracture surgery. World J Orthop. 2013 Oct 18;4(4):248-58. doi: 10.5312/wjo.v4.i4.248. eCollection 2013.
PubMed 24147260Hulsbaek S, Juhl C, Ropke A, Bandholm T, Kristensen MT. Exercise Therapy Is Effective at Improving Short- and Long-Term Mobility, Activities of Daily Living, and Balance in Older Patients Following Hip Fracture: A Systematic Review and Meta-Analysis. J Gerontol A Biol Sci Med Sci. 2022 Apr 1;77(4):861-871. doi: 10.1093/gerona/glab236.
PubMed 34387664Kristensen MT. Factors affecting functional prognosis of patients with hip fracture. Eur J Phys Rehabil Med. 2011 Jun;47(2):257-64.
PubMed 21597435Rosell PA, Parker MJ. Functional outcome after hip fracture. A 1-year prospective outcome study of 275 patients. Injury. 2003 Jul;34(7):529-32. doi: 10.1016/s0020-1383(02)00414-x.
PubMed 12832181Ariza-Vega P, Jimenez-Moleon JJ, Kristensen MT. Change of residence and functional status within three months and one year following hip fracture surgery. Disabil Rehabil. 2014;36(8):685-90. doi: 10.3109/09638288.2013.813081. Epub 2013 Aug 6.
PubMed 23919643Egan M, Jaglal S, Byrne K, Wells J, Stolee P. Factors associated with a second hip fracture: a systematic review. Clin Rehabil. 2008 Mar;22(3):272-82. doi: 10.1177/0269215507081573. Epub 2007 Dec 5.
PubMed 18057086Auais MA, Eilayyan O, Mayo NE. Extended exercise rehabilitation after hip fracture improves patients' physical function: a systematic review and meta-analysis. Phys Ther. 2012 Nov;92(11):1437-51. doi: 10.2522/ptj.20110274. Epub 2012 Jul 19.
PubMed 22822235Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
PubMed 31343601Schoenfeld BJ, Ogborn D, Krieger JW. Dose-response relationship between weekly resistance training volume and increases in muscle mass: A systematic review and meta-analysis. J Sports Sci. 2017 Jun;35(11):1073-1082. doi: 10.1080/02640414.2016.1210197. Epub 2016 Jul 19.
PubMed 27433992Borde R, Hortobagyi T, Granacher U. Dose-Response Relationships of Resistance Training in Healthy Old Adults: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1693-720. doi: 10.1007/s40279-015-0385-9.
PubMed 26420238Nobrega SR, Libardi CA. Is Resistance Training to Muscular Failure Necessary? Front Physiol. 2016 Jan 29;7:10. doi: 10.3389/fphys.2016.00010. eCollection 2016. No abstract available.
PubMed 26858654de Sousa DG, Harvey LA, Dorsch S, Varettas B, Jamieson S, Murphy A, Giaccari S. Two weeks of intensive sit-to-stand training in addition to usual care improves sit-to-stand ability in people who are unable to stand up independently after stroke: a randomised trial. J Physiother. 2019 Jul;65(3):152-158. doi: 10.1016/j.jphys.2019.05.007. Epub 2019 Jun 18.
PubMed 31227279Yoshimura Y, Wakabayashi H, Nagano F, Bise T, Shimazu S, Shiraishi A. Chair-stand exercise improves post-stroke dysphagia. Geriatr Gerontol Int. 2020 Oct;20(10):885-891. doi: 10.1111/ggi.13998. Epub 2020 Aug 9.
PubMed 32772455
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture. A Non-randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT05840315
- Acronym / sponsor ID
- RSS protokol Hoftefrak
- Conditions
- Hip Fractures, Sarcopenia, Fall Injury
- Keywords
- physical therapy, resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Horsholm MunicipalityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 3 May 2023 (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 objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program.
Feasibility criteria is defined as: 1) hip fracture-related pain might increase during the exercise programme, but not persistent after each session. 2) adherence to the program must be 75% or more. 3) Less than 20% drop-outs due to pain and/or discomfort during training.
Detailed description
Background and rationale:
Hip fractures are associated with decrease in muscle strength, Rehabilitation after hip fractures typically include types of resistance training, functional training and cardiovascular training Factors affecting the functional prognosis after hip fracture surgery are multiple, and patients are at risk of decreased physical function new injurious falls and fractures and increased need of supportive care.
Earlier research has shown that daily on weekdays, progressive knee-extension strength training (three sets with a 10RM load) is a feasible and potentially effective treatment for increasing muscle strength in patients with hip fractures when commenced few days after surgery.
Extended physical therapy including strength training implemented about 6 weeks or later after hip fracture surgery seem to promote recovery of physical function.
The goal of rehabilitation is to reach the highest degree of autonomy as possible, which in sarcopenic older adults requires increasing the muscle strength in the lower extremities. Higher volume resistance training has been associated with increased muscle mass and strength in both young and older populations Resistance training for elderly patients is usually done to failure to ensure adequate volume for muscle hypertrophy and strength increases.
In comparison, Sit-to-stand chair exercises has earlier been executed as progressive training and shows promising results as to increasing ability to rise from a lower chair In stroke patients. Sit-to-stand exercise has been shown to be a good whole body exercise and with effects of the exercises ranging from increased leg strength to association with lower degree of dysphagia in stroke patients, when done in addition to the convalescence rehabilitation program.
To the researchers knowledge there exist no other trials testing systematic use of very high training volume of sit-to-stand exercises in rehabilitation of older patients with hip fractures.
This trial searches to combine training with high volume of sit-to-stand exercises with training to volitional failure on leg press and hip abductions to employ combinations of heavy, progressive resistance training and very high volume of total training (29 sets per week) Objectives The objective of this study is to examine if functional high-density, high-volume chair rise training is feasible for increasing lower extremity strength without causing excessive hip pain during execution in patients with hip fracture following a municipality -based outpatient rehabilitation program.
Feasibility criteria is defined as: 1) hip fracture-related pain might increase during the exercise programme, but not persistent after each session. 2) adherence to the program must be 75% or more. 3) Less than 20% drop-outs due to pain and/or discomfort during training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three stages of single arm non-randomized feasibility trial set-up, testing an interventions feasibility, combined with the usual rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Dietary Supplement: Basic intervention and nutritional intervention, Procedure: Sit-to-standFirst subtrial (participants 1-10): Sit-to-stand-to-sit training |
| Phase 2 | Experimental | Dietary Supplement: Basic intervention and nutritional intervention, Procedure: Sit-to-stand, Procedure: Leg pressSecond subtrial (participants 11-20): Sit-to-stand and leg press training. |
| Phase 3 | Experimental | Dietary Supplement: Basic intervention and nutritional intervention, Procedure: Sit-to-stand, Procedure: Hip abductionThird subtrial (participants 21-30): Sit-to-stand and hip abduction training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Moderate to severe dementia
- Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
- Cancer
- Alcohol intake >21/14 units a week for men/women.
- Patients not allowed full weight bearing on the fractured leg
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 |
|---|---|---|
| Basic intervention and nutritional interventionAlso: Nutritional interventionThe training plan is divided into 3 parts with different sub-components. There will be ongoing enrollment until 10 participants have been recruited, after which the next sub-trial will start recruitment. The intervention from the respective sub-trials is described in the individual study phases. Participants attend one-hour exercise sessions, 2 times/week for 8 weeks, in groups of 4-7 patients, supervised by 2-3 physio therapists. After completion of the physical intervention all participants are given a nutritional supplement, being a 200ml cocoa(Chokolate milk), containing 7 grams of protein, 24grams of carbohydrates, 5 grams of fat and in total 166 kilocalories. If any participant has lactose intolerance or diabetes, they are advised to bring an egg and a piece of rye bread to secure an equal amount of protein and calories. | Dietary supplement | Phase 1, Phase 2, Phase 3 |
| Sit-to-standAlso: Resistance trainingFirst subtrial (participants 1-10): Sit-to-stand-to-sit training: Participants will be instructed to do as many sit-to-stand repetitions as possible without using their arms in a 30 second window, followed by a 30 second rest. This sequence is repeated for a total of 10 sets (a total of 10 minutes). Standard seat height of chair is 46 cm. Progression/regression: If a participant is unable to do at least 6 repetitions on the first sit-to-stand test, they are allowed to sit on a 6cm airex pillow while performing the exercise. When a single set of 12 chair rises are attained or total amount of repetitions reach 100 in 10 sets on an airex, the participant progresses to sitting on a 6-0,5cm wedge pillow, and again when the participant attains 12 rises, he/she progress to rising from the standard chair height. | Procedure or surgery | Phase 1, Phase 2, Phase 3 |
| Leg pressAlso: Resistance trainingSecond subtrial (participants 11-20): In addition to the above intervention, progressive strength training is performed on a leg press, consisting of 3 sets of 8-12RM. Participants are instructed to do as many repetitions as possible, and the weight is increased if either 12 repetitions are performed on three consecutive sets or a single set or more than 14 repetitions are completed. If fewer than 6 repetitions are performed, the weight is reduced . There is a minimum of one minute break between each set of training on the leg press. | Procedure or surgery | Phase 2 |
| Hip abductionAlso: Resistance trainingThird subtrial (participants 21-30): In addition to interventions described in sub-trial 1, Third subtrial will perform progressive strength training for the gluteal muscles is carried out in form of hip abduction, using rubber bands, consisting of 3 sets of 8-12RM using the same procedure as above mentioned for the leg press. Hip abduction will be performed from a standing position with a straight arm length from a wall, supporting the wall. The participant will be instructed to abduct the hip facing the wall until the foot is in contact with the wall, and then back until it touches the standing leg. Progression will be placing a rubber band just proximal to the knee with resistances being: yellow= light, red= moderate, blue= heavy. further progression will be placing the rubber band around the ankles using the same progression as above. | Procedure or surgery | Phase 3 |
Primary outcome
Feasibility of the interventions; Adherence
Time frame: Measured during the 8 week intervention
Feasibility is evaluated based on adherence to the program. Adherence to the program must be 75% or more, and drop outs due to pain or discomfort during training should be no more than 20%.
Tolerability of the interventions; Hip fracture related pain
Time frame: Measured during the 8 week intervention
Hip fracture-related pain during exercise, and dropouts. Hip fracture-related pain should not increase to more than a maximum of 3 VRS points (severe pain) during exercise and reduced thereafter, Patient rating pain on a verbal rating scale of 0-4 0: no pain, 1: slight pain, 2: Moderate pain, 3: severe pain and 4: Unbearable pain.
9 secondary outcomes
Sit-to-stand- test
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
Change in 10m walk test, using regular walk speed and standing start.
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
Change in Handgrip strength
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
SARC-F questionnaire
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
Prevalence and severity of sarcopenia
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
New mobility score
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall)
Falls Efficacy Scale-International
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
Quality of life by EQ5D-5L
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
Quality of life by EQ-VAS
Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period
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 6 Mar 2026.
- Background: PubMed 24699276Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Feasibility of progressive strength training implemented in the acute ward after hip fracture surgery. PLoS One. 2014 Apr 3;9(4):e93332. doi: 10.1371/journal.pone.0093332. eCollection 2014.
- Background: PubMed 19091449Kristensen MT, Bandholm T, Bencke J, Ekdahl C, Kehlet H. Knee-extension strength, postural control and function are related to fracture type and thigh edema in patients with hip fracture. Clin Biomech (Bristol). 2009 Feb;24(2):218-24. doi: 10.1016/j.clinbiomech.2008.10.003. Epub 2008 Dec 16.
- Background: PubMed 24147260Overgaard J, Kristensen MT. Feasibility of progressive strength training shortly after hip fracture surgery. World J Orthop. 2013 Oct 18;4(4):248-58. doi: 10.5312/wjo.v4.i4.248. eCollection 2013.
- Background: PubMed 34387664Hulsbaek S, Juhl C, Ropke A, Bandholm T, Kristensen MT. Exercise Therapy Is Effective at Improving Short- and Long-Term Mobility, Activities of Daily Living, and Balance in Older Patients Following Hip Fracture: A Systematic Review and Meta-Analysis. J Gerontol A Biol Sci Med Sci. 2022 Apr 1;77(4):861-871. doi: 10.1093/gerona/glab236.
- Background: PubMed 21597435Kristensen MT. Factors affecting functional prognosis of patients with hip fracture. Eur J Phys Rehabil Med. 2011 Jun;47(2):257-64.
- Background: PubMed 12832181Rosell PA, Parker MJ. Functional outcome after hip fracture. A 1-year prospective outcome study of 275 patients. Injury. 2003 Jul;34(7):529-32. doi: 10.1016/s0020-1383(02)00414-x.
- Background: PubMed 23919643Ariza-Vega P, Jimenez-Moleon JJ, Kristensen MT. Change of residence and functional status within three months and one year following hip fracture surgery. Disabil Rehabil. 2014;36(8):685-90. doi: 10.3109/09638288.2013.813081. Epub 2013 Aug 6.
- Background: PubMed 18057086Egan M, Jaglal S, Byrne K, Wells J, Stolee P. Factors associated with a second hip fracture: a systematic review. Clin Rehabil. 2008 Mar;22(3):272-82. doi: 10.1177/0269215507081573. Epub 2007 Dec 5.
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- Background: PubMed 31343601Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
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- 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.
Niklas Grundt Hansen, Msc. PT principal investigator
Research therapist, Hørsholm municipality, capital region
Morten Ta Kristensen, Professor study director
Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg hospitals, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic intervention and nutritional intervention, Sit-to-stand and Leg press in people with Hip Fractures and Sarcopenia, run by Horsholm Municipality at 1 site in Denmark.
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 0 inclusion and 6 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 6 Mar 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 Denmark. 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?
Feasibility of the interventions; Adherence (time frame: Measured during the 8 week intervention). The study lists 2 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 NCT05840315, which also lists 25 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 6 Mar 2026.