Inspiratory Muscle Training in Individuals With Multiple Sclerosis
- Sponsor
- Istanbul University - Cerrahpasa
- Study ID
- NCT07672535
- Status
- Not Yet Recruiting
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Conditions
- Inspiratory Muscle Training
- Multiple Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- High intensity interval IMT — BEHAVIORALParticipants with multiple sclerosis (MS) in this group will perform high intensity interval inspiratory muscle training (IMT) for 8 weeks, three times per week (one supervised by a physiotherapist and two home-based sessions). The protocol consists of 7 cycles of 2 minutes of exercise followed by 1 minute of rest, with each session lasting 21 minutes. Training intensity will start at 30% of maximal inspiratory pressure (MIP) and progressively increase to 70% by the third week. From week 4 onward, intensity will be maintained at 70% of MIP and adjusted according to tolerance, based on a Borg scale rating of 3-5. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.
- Low intensity IMT — BEHAVIORALParticipants with multiple sclerosis (MS) in this group will perform low intensity inspiratory muscle training (IMT) for 8 weeks, consisting of five sessions per week: one supervised by a physiotherapist and four home-based supervised sessions. The training will be performed as two daily sessions of 15 minutes each, totaling 30 minutes per day. Low intensity IMT will be conducted at 30% of maximal inspiratory pressure (MIP). Training intensity will be reassessed and adjusted to 30% of MIP every two weeks during supervised sessions, based on repeated MIP measurements. During training, participants will be instructed to maintain a seated position with the upper chest and shoulders in a relaxed posture. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.
- Conventional rehabilitation — BEHAVIORALParticipants in this group will undergo a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised by a physiotherapist and two home-based supervised sessions. Each session will last approximately 40 minutes. The program will include warm-up exercises, aerobic exercises, strengthening exercises, balance exercises, and cool-down exercises.
Study Details
Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, characterized by inflammation, demyelination, and axonal degeneration, and primarily affects young adults. Muscle weakness, sensory disturbances, spasticity, pain, visual impairment, ataxia, fatigue, cognitive dysfunction, and respiratory complications are among the most commonly reported symptoms in individuals with MS. Although inspiratory muscle training has been shown to have beneficial effects in individuals with MS, the effects of different inspiratory muscle training intensities on respiratory muscle strength and pulmonary function have not been sufficiently investigated. The primary aim of this study is to investigate the effectiveness and clinical feasibility of high-intensity interval inspiratory muscle training in individuals with MS. The secondary aim is to compare the effects of high-intensity interval inspiratory muscle training, low-intensity inspiratory muscle training, and conventional rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life in individuals with MS. Participants will be randomly assigned to one of three groups: a high-intensity interval inspiratory muscle training group, a low-intensity inspiratory muscle training group, or a conventional rehabilitation group. All three groups will receive conventional rehabilitation, while the inspiratory muscle training groups will additionally receive their respective inspiratory muscle training programs. This study aims to be the first randomized controlled trial to evaluate the effects of high-intensity interval inspiratory muscle training in individuals with MS.
Key Dates
- First listed
- Jun 29, 2026
- Start date
- Aug 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: High intensity interval IMT groupHigh-intensity interval IMT and conventional rehabilitation
- Experimental: Low intensity IMT groupLow intensity IMT and conventional rehabilitation
- Active Comparator: Conventional rehabilitationConventional rehabilitation
Primary Outcome Measure
Maximal inspiratory pressure (MIP) [ Time Frame: From baseline to the end of the intervention at 8 weeks ]
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