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Completed

NCT Number: NCT05840315

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hørsholm municipality

Hørsholm, Capitol Region, 2970, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Nutritional intervention

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.

Other names: Resistance training

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.

Other names: Resistance training

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.

Other names: Resistance training

Primary outcomes

  1. 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%.

  2. 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.

Secondary outcomes

  1. Sit-to-stand- test

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

    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).

  2. 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

    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).

  3. Change in Handgrip strength

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

    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)

  4. SARC-F questionnaire

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

    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).

  5. Prevalence and severity of sarcopenia

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

    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).

  6. New mobility score

    Time frame: Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall)

    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).

  7. Falls Efficacy Scale-International

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

    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).

  8. Quality of life by EQ5D-5L

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

    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

  9. Quality of life by EQ-VAS

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

    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

Other outcomes

  1. BMI (kg/m2)

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

    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.

  2. Body composition

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

    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.

  3. Home care

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

    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.

Sponsors and collaborators

Lead sponsor

Horsholm Municipality

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 3, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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