Inspiratory Muscle Training in Individuals With Multiple Sclerosis

Sponsor
Istanbul University - Cerrahpasa
Study ID
NCT07672535
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • High intensity interval IMT — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants 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 group
    High-intensity interval IMT and conventional rehabilitation
  • Experimental: Low intensity IMT group
    Low intensity IMT and conventional rehabilitation
  • Active Comparator: Conventional rehabilitation
    Conventional 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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