Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture

Sarcopenia Clinical Trial

Official title:

Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture. A Non-randomized Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840315
• Other study ID #: RSS protokol Hoftefrak
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2023
• Source: Horsholm Municipality
• Contact: Niklas Grundt Hansen, Msc. PT
• Phone: +4561277932
• Email: Grundt.niklas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Study setting Training and data collection will be executed at a rehabilitation centre in Hørsholm municipality, capital region, Denmark.

Eligibility criteria Patients with hip fractures having

• Referred to rehabilitation due to hip fracture

• Age of 60 years or older

• Cumulated Ambulation Score 5 or higher

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Fall Injury
• Fractures, Bone
• Hip Fractures
• Sarcopenia

Intervention

Dietary Supplement:
• Basic intervention and 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.

Procedure:
• Sit-to-stand
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 press
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 abduction
Third subtrial (participants 21-30): In addition to interventions described in sub-trials 1 and 2, progressive strength training of the gluteal muscles is carried out in the form of hip abduction from a sitting position, using a hip abduction machine, consisting of 3 sets of 8-12RM using the same procedure as above mentioned for the leg press.

Locations

Country	Name	City	State
Denmark	Hørsholm municipality	Hørsholm	Capitol Region

Sponsors (1)

Lead Sponsor	Collaborator
Horsholm Municipality

Country where clinical trial is conducted

Denmark, 

References & Publications (25)

Andersen CW, Kristensen MT. Performance Stability and Interrater Reliability of Culturally Adapted 10-Meter Walking Test for Danes with Neurological Disorders. J Stroke Cerebrovasc Dis. 2019 Sep;28(9):2459-2467. doi: 10.1016/j.jstrokecerebrovasdis.2019.06.021. Epub 2019 Jul 4. — View Citation

Ariza-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. — View Citation

Auais 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. — View Citation

Bech RD, Lauritsen J, Ovesen O, Overgaard S. The Verbal Rating Scale Is Reliable for Assessment of Postoperative Pain in Hip Fracture Patients. Pain Res Treat. 2015;2015:676212. doi: 10.1155/2015/676212. Epub 2015 May 20. — View Citation

Borde 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. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

de 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. — View Citation

Egan 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. — View Citation

Fragala 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. — View Citation

Hulsbaek 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. — View Citation

Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20. — View Citation

Kristensen 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, Avon). 2009 Feb;24(2):218-24. doi: 10.1016/j.clinbiomech.2008.10.003. Epub 2008 Dec 16. — View Citation

Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med. 2008 Jul;40(7):589-91. doi: 10.2340/16501977-0217. — View Citation

Kristensen MT, Dall CH, Aadahl M, Suetta C. Systematic assessment of physical function in adult patients across diagnoses. Ugeskr Laeger. 2022 Oct 24;184(43):V02220134. Danish. — View Citation

Kristensen MT, Foss NB. Danish version of Verbal Rating Scale (VRS 0-4 points) - Verbal Rang Skala (VRS). [Internet]. Unpublished; 2020 [henvist 7. marts 2023]. Tilgængelig hos: http://rgdoi.net/10.13140/RG.2.2.19739.41769/2

Kristensen MT, Kehlet H. Most patients regain prefracture basic mobility after hip fracture surgery in a fast-track programme. Dan Med J. 2012 Jun;59(6):A4447. — View Citation

Kristensen MT. Factors affecting functional prognosis of patients with hip fracture. Eur J Phys Rehabil Med. 2011 Jun;47(2):257-64. — View Citation

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. — View Citation

Nobrega 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. — View Citation

Overgaard 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. — View Citation

Rosell 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. — View Citation

Schoenfeld 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. — View Citation

Sorensen J, Davidsen M, Gudex C, Pedersen KM, Bronnum-Hansen H. Danish EQ-5D population norms. Scand J Public Health. 2009 Jul;37(5):467-74. doi: 10.1177/1403494809105286. Epub 2009 Jun 17. — View Citation

Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009 Jul;37(5):459-66. doi: 10.1177/1403494809105287. Epub 2009 May 1. — View Citation

Yoshimura 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI (kg/m2)	body weight in kg will be measured on a regular scale and to the nearest 100 grams. Participants will be weighed without shoes and with as little clothes as possible. Height will be measured on bare feet with a yardstick fixed to the wall and to the nearest cm. There will be determined if lower BMI or muscle mass results in less effect of an physical therapy intervention.	Baseline(within the first week before starting the intervention) and immediately post intervention period
Other	Body composition	Changes in body composition (muscle mass) during the intervention. Body composition will be determined on at Tanita scale, measuring body composition via bioimpedance. There will be determined if lower BMI or muscle mass results in less effect of an physical therapy intervention.	Baseline(within the first week before starting the intervention) and immediately post intervention period
Other	Home care	The amount of hours dedicated to home care on a weekly basis from pre-fracture, at enrollment of intervention and after the end of intervention.	Measured pre-fracure (by recall), Baseline, immediately post intervention period and after 3 and 6 months after completing the intervention.
Primary	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 during the 8 week intervention
Primary	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 during the 8 week intervention
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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)	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall)
Secondary	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).	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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	Baseline(within the first week before starting the intervention) and immediately post intervention period
Secondary	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	Baseline(within the first week before starting the intervention) and immediately post intervention period