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

Primary Purpose

Hip Fractures, Sarcopenia, Fall Injury

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Basic intervention and nutritional intervention
Sit-to-stand
Leg press
Hip abduction
Sponsored by
Horsholm Municipality
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring physical therapy, resistance training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hørsholm municipalityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1

Phase 2

Phase 3

Arm Description

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

Second subtrial (participants 11-20): Sit-to-stand and leg press training.

Third subtrial (participants 21-30): Sit-to-stand, leg press training and hip abduction training.

Outcomes

Primary Outcome Measures

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%.
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.

Secondary Outcome Measures

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).
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).
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)
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).
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).
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).
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).
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
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

Full Information

First Posted
March 22, 2023
Last Updated
April 28, 2023
Sponsor
Horsholm Municipality
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1. Study Identification

Unique Protocol Identification Number
NCT05840315
Brief Title
Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture
Official Title
Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture. A Non-randomized Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horsholm Municipality

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Sarcopenia, Fall Injury
Keywords
physical therapy, resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Arm Description
First subtrial (participants 1-10): Sit-to-stand-to-sit training
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Second subtrial (participants 11-20): Sit-to-stand and leg press training.
Arm Title
Phase 3
Arm Type
Experimental
Arm Description
Third subtrial (participants 21-30): Sit-to-stand, leg press training and hip abduction training.
Intervention Type
Dietary Supplement
Intervention Name(s)
Basic intervention and nutritional intervention
Other Intervention Name(s)
Nutritional intervention
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sit-to-stand
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Leg press
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hip abduction
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the interventions; Adherence
Description
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%.
Time Frame
Measured during the 8 week intervention
Title
Tolerability of the interventions; Hip fracture related pain
Description
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.
Time Frame
Measured during the 8 week intervention
Secondary Outcome Measure Information:
Title
Sit-to-stand- test
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Change in 10m walk test, using regular walk speed and standing start.
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Change in Handgrip strength
Description
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)
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
SARC-F questionnaire
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Prevalence and severity of sarcopenia
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
New mobility score
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period,(including pre-fracture by recall)
Title
Falls Efficacy Scale-International
Description
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).
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Quality of life by EQ5D-5L
Description
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
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Quality of life by EQ-VAS
Description
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
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Other Pre-specified Outcome Measures:
Title
BMI (kg/m2)
Description
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.
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Body composition
Description
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.
Time Frame
Baseline(within the first week before starting the intervention) and immediately post intervention period
Title
Home care
Description
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.
Time Frame
Measured pre-fracure (by recall), Baseline, immediately post intervention period and after 3 and 6 months after completing the intervention.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Grundt Hansen, Msc. PT
Phone
+4561277932
Email
Grundt.niklas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Ta Kristensen, Professor
Email
Morten.tange.kristensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Grundt Hansen, Msc. PT
Organizational Affiliation
Research therapist, Hørsholm municipality, capital region
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten Ta Kristensen, Professor
Organizational Affiliation
Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg hospitals, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Hørsholm municipality
City
Hørsholm
State/Province
Capitol Region
ZIP/Postal Code
2970
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Grundt, Msc. PT
Phone
+4561277932
Email
grundt.niklas@gmail.com
First Name & Middle Initial & Last Name & Degree
Pernille Ba Neiman, Msc.
Phone
29232330
Email
PBA@horsholm.dk

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Feasibility of High Density Sit-to-stand Functional Resistance Training in Patients With Hip Fracture

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