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

NCT05840315 | Completed DMC

• 1 other identifier: RSS protokol Hoftefrak
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Fractures; Sarcopenia; Fall Injury

Keywords

physical therapy; resistance training

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Sit-to-stand- test

  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.

  Baseline(within the first week before starting the intervention) and immediately post intervention period

• Change in Handgrip strength

  Baseline(within the first week before starting the intervention) and immediately post intervention period

• SARC-F questionnaire

  Baseline(within the first week before starting the intervention) and immediately post intervention period

• Prevalence and severity of sarcopenia

  Baseline(within the first week before starting the intervention) and immediately post intervention period

Other Outcomes (3)

• BMI (kg/m2)

  Baseline(within the first week before starting the intervention) and immediately post intervention period

• Body composition

  Baseline(within the first week before starting the intervention) and immediately post intervention period

• Home care

  Measured pre-fracure (by recall), Baseline, immediately post intervention period and after 3 and 6 months after completing the intervention.

Study Arms (3)

Phase 1

EXPERIMENTAL

First subtrial (participants 1-10): Sit-to-stand-to-sit training

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.

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.

Dietary Supplement: Basic intervention and nutritional intervention; Procedure: Sit-to-stand; Procedure: Hip abduction

Interventions

Sit-to-stand PROCEDURE

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.

Also known as: Resistance training

Phase 1; Phase 2; Phase 3

Leg press PROCEDURE

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.

Also known as: Resistance training

Phase 2

Hip abduction PROCEDURE

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.

Also known as: Resistance training

Phase 3

Basic intervention and nutritional intervention DIETARY_SUPPLEMENT

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.

Also known as: Nutritional intervention

Phase 1; Phase 2; Phase 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Horsholm Municipality: lead

Study Sites (1)

Hørsholm municipality

Hørsholm, Capitol Region, 2970, Denmark

Location

Related Publications (25)

• 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.

  PMID: 24699276 BACKGROUND

• 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). 2009 Feb;24(2):218-24. doi: 10.1016/j.clinbiomech.2008.10.003. Epub 2008 Dec 16.

  PMID: 19091449 BACKGROUND

• 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.

  PMID: 24147260 BACKGROUND

• 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.

  PMID: 34387664 BACKGROUND

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

  PMID: 21597435 BACKGROUND

• 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.

  PMID: 12832181 BACKGROUND

• 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.

  PMID: 23919643 BACKGROUND

• 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.

  PMID: 18057086 BACKGROUND

• 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.

  PMID: 22822235 BACKGROUND

• 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.

  PMID: 31343601 BACKGROUND

• 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.

  PMID: 27433992 BACKGROUND

• 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.

  PMID: 26420238 BACKGROUND

• 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.

  PMID: 26858654 BACKGROUND

• 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.

  PMID: 31227279 BACKGROUND

• 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.

  PMID: 32772455 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26078880 BACKGROUND

• 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.

  PMID: 36331169 BACKGROUND

• 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.

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  PMID: 30312372 BACKGROUND

• 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.

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MeSH Terms

Conditions

Hip Fractures; Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Niklas Grundt Hansen, Msc. PT

  Research therapist, Hørsholm municipality, capital region

  PRINCIPAL INVESTIGATOR

• Morten Ta Kristensen, Professor

  Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg hospitals, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Therapist

Model Details: Three stages of single arm non-randomized feasibility trial set-up, testing an interventions feasibility, combined with the usual rehabilitation program.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 3, 2023
• Study Start: March 21, 2023
• Primary Completion: September 1, 2025
• Study Completion: February 6, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)