Blood Flow Restriction (BFR) Training Effects, Frailty Syndrome, Inspiratory Muscle Training, Older Adults
Conditions
Keywords
frailty, older adults, blood flow restriction, inspiratory muscle training
Brief summary
This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.
Detailed description
This is a parallel randomized controlled trial. 30 participants who are older adults with frailty will be enrolled. Eligible participants who complete the baseline measurements will be randomly allocated to a combined BFR and IMT intervention group (N=15) or in the control group with BFR and sham IMT (N=15). Primary outcomes include feasibility and physical function (i.e., the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), and Time Up and Go (TUG) test). Secondary outcomes include respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events. All outcomes will be assessed at baseline (T0) and immediately after the 6-week intervention period (T1) in both groups.
Interventions
BEHAVIORALExercise
Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity. For the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance. For the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.
BEHAVIORALSham Control
Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function
Sponsors
Taipei Medical University
National Taiwan University
The University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
We will implement a double-masking protocol, ensuring that participants and outcome assessors are all blinded to group assignments. Additionally, group assignments will also be masked from the data analyzer to minimize potential bias.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Community-dwelling adults aged 65 years and older who are classified as at least "vulnerable" using the Clinical Frailty Scale (score ≥4). * Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE).
Exclusion criteria
* (1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders) * (2) have high-risk factors for exercise, such as uncontrolled hypertension (\>150 mmHg systolic blood pressure (SBP) / \>90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis * (3) have hematological disorders or are using hematology related-medications * (4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases * (5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and * (6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | T0 = baseline; T1 = immediately after intervention | The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants |
| Attrition rate | T0 = baseline; T1 = immediately after intervention | Attrition rate is the proportion of randomized participants who withdraw from the study or are lost to follow-up before completing the final assessment. |
| Exercise Enjoyment | T0 = baseline; T1 = immediately after intervention | Enjoyment will be assessed using a single-item Exercise Enjoyment Scale, which asks participants, "How much did you enjoy the exercise session?). Responses are rated on a 7 Likert scale ranging from 1 (not at all) to 7 (extremely) |
| Short Physical Performance Battery (SPPB) | T0 = baseline; T1 = immediately after intervention | The SPPB consists of three components-standing balance, gait speed, and repeated chair stands-each scored from 0 to 4 and summed to a total score ranging from 0 (worst performance) to 12 (best performance). Lower SPPB scores indicate poorer physical function and a higher risk of adverse outcomes, with scores below 10 predictive of all-cause mortality in older adults. |
| 6-Minute Walk Test (6MWT) | T0 = baseline; T1 = immediately after intervention | The 6MWT will be used to assess functional exercise capacity. Participants will be instructed to walk as far as possible along a flat, straight course for 6 minutes, and the total distance is recorded. |
| Time Up to Go (TUG) | T0 = baseline; T1 = immediately after intervention | The TUG test is used to assess functional mobility, balance, and fall risk in older adults, incorporating a series of dynamic activities. Participants will be instructed to rise from a chair, walk three meters at a comfortable pace, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded, with longer times indicating poorer functional mobility and higher fall risk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Muscle Strength | T0 = baseline; T1 = immediately after intervention | We will use the S-Index Test to evaluate the respiratory muscle function based on maximum dynamic inspiratory pressure, which is a recommended tool developed by POWERbreathe. Participants will be advised to avoid strenuous exercise for 24h and to rest in a sitting position for 15 minutes before the assessment. Then, they performed eight inspiratory maneuvers in a standing position, divided into three to four series of two to three repetitions. |
| Handgrip Strength | T0 = baseline; T1 = immediately after intervention | Handgrip strength will be evaluated to estimate the maximum upper-limb muscle function in older adults. Participants will be seated with the shoulder adducted, the elbow flexed to 90°, and the forearm and wrist in a neutral position. They will then be instructed to squeeze the dynamometer as forcefully as possible. |
| Five-times sit-to-stand | T0 = baseline; T1 = immediately after intervention | The five-times sit-to-stand test is simple to administer and has been widely applied in both clinical and research settings. Participants will sit with their backs against the chair and be instructed to stand and sit five times as quickly as possible. |
| Frailty level | T0 = baseline; T1 = immediately after intervention | The Clinical Frailty Scale (CFS) is a 9-point global clinical measure ranging from 1 (very fit) to 9 (terminally ill), used to classify frailty severity in older adults. A traditional Chinese version of the CFS has been validated in Taiwanese older adults, demonstrating acceptable inter-rater reliability and good criterion validity against established frailty measures |
| Fall Efficacy | T0 = baseline; T1 = immediately after intervention | The short form of the Falls Efficacy Scale-International (FES-I) includes 7 items rated on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned). The total score ranges from 7 to 28, with higher values indicating greater concern about falling |
| Adverse events | T0 = baseline; T1 = immediately after intervention | The study team will record adverse events during the intervention caused by the exercise, including falls, fractures, exercise-related pain, dizziness, muscle strain, sprains, respiratory and cardiac adverse events, and hospitalization. |
| Fat mass | T0 = baseline; T1 = immediately after intervention | Fat mass will be assessed using a body composition analyzer and recorded in kilograms |
| Fat-free mass | T0 = baseline; T1 = immediately after intervention | Fat-free mass will be assessed using a body composition analyzer and recorded in kilograms. |
Countries
Taiwan
Contacts
CONTACTPei-Shan Tsai Professor, PhD
Outcome results
None listed